RAC Drug Workshop Slides - Global 2022 - Questions and Answers

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GLOBAL CONCEPTS
50 QUESTION/ANSWER PAIRS
FEBRUARY 8-9, 2022
GLOBAL QUESTION 1
Which type of medicinal product must be screened for long-term carcinogenicity?

1 Radiolabeled imaging agents
2 Agents for the treatment of late-stage cancer
3 Insulin for animals or human use
4 Adjuvant therapy agents for tumor-free patients
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GLOBAL ANSWER 1
Which type of medicinal product must be screened for long-term carcinogenicity?

1 Radiolabeled imaging agents
2 Agents for the treatment of late-stage cancer
3 Insulin for animals or human use
4 Adjuvant therapy agents for tumor-free patients
ICH S1A, Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals, November 1995. In cases where the
therapeutic agent for cancer generally is successful and life is prolonged significantly, there may be later concerns regarding
secondary cancers. When such pharmaceuticals are intended for adjuvant therapy in tumor-free patients or for prolonged use
in non-cancer indications, carcinogenicity studies usually are needed.
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GLOBAL QUESTION 2
In designing a dose-ranging carcinogenicity study in rats, which consideration is the most important in
selecting the high dose?
1 100 times the maximum recommended human daily dose in male and female rats
2 The maximum tolerated dose in male and female rats
3 A dose high enough to alter physiological function in at least 50% of animals within 45 days
4 The cost of the study at a non-GLP laboratory
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GLOBAL ANSWER 2
In designing a dose-ranging carcinogenicity study in rats, which consideration is the most important in
selecting the high dose?
1 100 times the maximum recommended human daily dose in male and female rats
2 The maximum tolerated dose in male and female rats
3 A dose high enough to alter physiological function in at least 50% of animals within 45 days
4 The cost of the study at a non-GLP laboratory
ICH S1C(R2), Dose Selection for Carcinogenicity Studies of Pharmaceuticals, March 2008, p.2. Studies should be conducted in
both male and female rats. Dose-ranging studies should be conducted in accordance with sound scientific principles; however,
no consensus on endpoints other than the maximum tolerated dose has been reached. Dose-ranging studies should be
conducted for 90 days.
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GLOBAL QUESTION 3
New pharmaceutical products require an extensive assessment of their genotoxic potential. The standard
battery of genotoxicity testing for pharmaceuticals includes:
1 Ames test for gene mutation in bacteria, cytogenetic testing, and in vivo genotoxicity
2 Ames test for gene mutation in bacteria and in vivo genotoxicity in one tissue
3 Cytogenetic testing and in vivo genotoxicity in a single tissue type
4 Long-term carcinogenicity testing in two species
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GLOBAL ANSWER 3
New pharmaceutical products require an extensive assessment of their genotoxic potential. The standard
battery of genotoxicity testing for pharmaceuticals includes:
1 Ames test for gene mutation in bacteria, cytogenetic testing, and in vivo genotoxicity
2 Ames test for gene mutation in bacteria and in vivo genotoxicity in one tissue
3 Cytogenetic testing and in vivo genotoxicity in a single tissue type
4 Long-term carcinogenicity testing in two species
ICH S2(R1), Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use, November
2011, 2.2 Description of the Two Options for the Standard Battery, pp. 3-4.
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GLOBAL QUESTION 4
A company is conducting a GLP audit of its pharmacokinetic study in rats, which is being performed at a
contract laboratory. Which of the following is NOT a GLP violation?
1 The laboratory does not have records of its sanitation procedures

2 Staff training is not documented, but the study director says he trained them himself
3 The study director modified the test protocol
4 Disposal of the test article was not documented
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GLOBAL ANSWER 4
A company is conducting a GLP audit of its pharmacokinetic study in rats, which is being performed at a
contract laboratory. Which of the following is NOT a GLP violation?
1 The laboratory does not have records of its sanitation procedures

2 Staff training is not documented, but the study director says he trained them himself
3 The study director modified the test protocol
4 Disposal of the test article was not documented
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring (ENV/MC/CHEM(98)17, 1997). Each study must have an
approved written protocol and any changes or revisions must be signed by a competent person, usually the study director.
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GLOBAL QUESTION 5
In preparing a clinical study report for submission in two weeks, the regulatory professional discovers an
Informed Consent document is missing for one subject. What is the BEST course of action?
1 Ignore it and proceed with the submission; deal with the issue if the health authority asks a question
2 Prepare a note to file explaining the document is missing
3 Ask the clinical department to contact the investigator to obtain the informed consent on file for this subject
4 Remove the subject from the clinical trial report
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GLOBAL ANSWER 5
In preparing a clinical study report for submission in two weeks, the regulatory professional discovers an
Informed Consent document is missing for one subject. What is the BEST course of action?
1 Ignore it and proceed with the submission; deal with the issue if the health authority asks a question
2 Prepare a note to file explaining the document is missing
3 Ask the clinical department to contact the investigator to obtain the informed consent on file for this subject
4 Remove the subject from the clinical trial report
Declaration of Helsinki and ICH E6(R1), Guideline for Good Clinical Practice, June 1996. Obtaining Informed
Consent from human clinical subjects is a fundamental tenet of Good Clinical Practice. This WILL be checked at
audit. In this scenario, the best course of action is to check first whether an Informed Consent Form exists for this
patient. (If it is determined an Informed Consent Form does not exist, there obviously are bigger concerns.)
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GLOBAL QUESTION 6
A Certificate of Pharmaceutical Product (CPP) does NOT need to include:

1 Certificate number
2 Product name, dosage form, active ingredients
3 GMP status and inspection information
4 Names of the countries where product is approved
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GLOBAL ANSWER 6
A Certificate of Pharmaceutical Product (CPP) does NOT need to include:

1 Certificate number
2 Product name, dosage form, active ingredients
3 GMP status and inspection information
4 Names of the countries where product is approved
World Health Organization, model Certificate of a Pharmaceutical Product. The Certificate of Pharmaceutical Product has to contain information
regarding the name of the license holder, the exporting country and the importing country. It does not need to contain information on the names of
the countries where the product is approved.
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GLOBAL QUESTION 7
A routine audit of the Active Pharmaceutical Ingredient manufacturer for a product in Phase 3 clinical trials
reveals a new impurity appeared at a concentration of 0.4%. The batch containing this unknown impurity
has been used in patients. The company should do all of the following EXCEPT:
1 Ask the Quality Control group to reanalyze the batch.
2 Review the API specifications to ensure the presence of unknown impurities at 0.4% would not quarantine
the batch
3 Review previous batches to determine whether the impurity has been qualified by clinical or nonclinical
safety testing
4 Perform an investigation to determine the root cause of the change in purity
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GLOBAL ANSWER 7
A routine audit of the Active Pharmaceutical Ingredient manufacturer for a product in Phase 3 clinical trials
reveals a new impurity appeared at a concentration of 0.4%. The batch containing this unknown impurity
has been used in patients. The company should do all of the following EXCEPT:
1 Ask the Quality Control group to reanalyze the batch.
2 Review the API specifications to ensure the presence of unknown impurities at 0.4% would not quarantine
the batch
3 Review previous batches to determine whether the impurity has been qualified by clinical or nonclinical
safety testing
4 Perform an investigation to determine the root cause of the change in purity
ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients , November 2000 and ICH Q3A(R2),
Impurities in New Drug Substances, October 2006. Out-of-specification results cannot be retested into conformity.
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GLOBAL QUESTION 8
Mix-ups during manufacturing and packaging of pharmaceutical products are prevented best by following
all of the following Good Manufacturing Practices (GMPs) EXCEPT:
1 Physically separating products until they have been packaged
2 Documenting deviations from Standard Operating Procedures (SOPs)
3 Maintaining Informed Consent records for all patients using the product
4 Restricting access to production areas to authorized personnel only
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GLOBAL ANSWER 8
Mix-ups during manufacturing and packaging of pharmaceutical products are prevented best by following
all of the following Good Manufacturing Practices (GMPs) EXCEPT:
1 Physically separating products until they have been packaged
2 Documenting deviations from Standard Operating Procedures (SOPs)
3 Maintaining Informed Consent records for all patients using the product
4 Restricting access to production areas to authorized personnel only
PIC/S, Guide to Good Manufacturing Practice for Medicinal Products, Part I, PE 009-9, September 2009. Maintaining Informed Consent is Good
Clinical Practice, not Good Manufacturing Practice.
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GLOBAL QUESTION 9
WHO Technical Report Series No. 908, 2003 Annex 4, GMP states legal responsibility for release of batches
of finished pharmaceutical products lies with:
1 The Authorized Person
2 Quality Control
3 Quality Assurance
4 Management
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GLOBAL ANSWER 9
WHO Technical Report Series No. 908, 2003 Annex 4, GMP states legal responsibility for release of batches
of finished pharmaceutical products lies with:
1 The Authorized Person
2 Quality Control
3 Quality Assurance
4 Management
WHO Technical Report Series No. 908, 2003 Annex 4, GMP. The requirements and legal responsibilities vary in
different jurisdictions, but the Authorized Person is the best answer.
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GLOBAL QUESTION 10
Which of the following Active Pharmaceutical Ingredient (API) manufacturing process examples is NOT
covered by Good Manufacturing Practice (GMP)?
1 Purifying an API manufactured by chemical synthesis
2 Initial extraction of an API from plant sources
3 Isolating an API from animal tissues
4 Cell culture of a biotechnology product made from fermentation/cell culture
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GLOBAL ANSWER 10
Which of the following Active Pharmaceutical Ingredient (API) manufacturing process examples is NOT
covered by Good Manufacturing Practice (GMP)?
1 Purifying an API manufactured by chemical synthesis
2 Initial extraction of an API from plant sources
3 Isolating an API from animal tissues
4 Cell culture of a biotechnology product made from fermentation/cell culture
ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients , November 2000, p. 3. Cutting and initial
extraction from plant sources are not covered by GMP. Further extraction, physical processing and packaging are.
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GLOBAL QUESTION 11
A manufacturer is developing a new drug product. During development, forced degradation studies on the
drug substance indicate there might be a photolabile impurity. How much photostability testing is required
for the drug product?
1 One development batch and one confirmatory batch

2 Every third commercial batch
3 Nothing if the drug product is packaged in foil blisters
4 None, photostability testing is not required
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GLOBAL ANSWER 11
A manufacturer is developing a new drug product. During development, forced degradation studies on the
drug substance indicate there might be a photolabile impurity. How much photostability testing is required
for the drug product?
1 One development batch and one confirmatory batch

2 Every third commercial batch
3 Nothing if the drug product is packaged in foil blisters
4 None, photostability testing is not required
ICH Q1B, Stability Testing: Photostability Testing of New Drug Substances and Products, November 1996, p. 5. “Normally, only one batch of
drug product is tested during the development phase, and then the photostability characteristics should be confirmed on a single batch…”
According to ICH Q1B, for substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.
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GLOBAL QUESTION 12
A manufacturer is developing a new biologic product from cell culture that is freeze-dried to extend the
storage time. What types of stability studies should be included in the submission?
1 Real-time data on three batches of drug substance and three batches of drug product
2 Real-time data on three batches of drug substance and three batches of drug product, plus accelerated
studies and shipping studies
studies and reconstitution studies
studies and shipping studies and reconstitution studies
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GLOBAL ANSWER 12
A manufacturer is developing a new biologic product from cell culture that is freeze-dried to extend the
storage time. What types of stability studies should be included in the submission?
1 Real-time data on three batches of drug substance and three batches of drug product
studies and shipping studies
studies and reconstitution studies
studies and shipping studies and reconstitution studies
ICH Q5C, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, November 1995. ICH Q5C discusses
the stability of both drug substances and drug product, in Section 6.3, accelerated and stress conditions (transport) and in Section 6.6, stability
after reconstitution. Therefore, 4 is the correct answer.
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GLOBAL QUESTION 13
A regulatory professional at a pharmaceutical manufacturing facility is training the production staff on

what questions to expect during an upcoming PIC/S audit. All of the following cover critical aspects of GMP
compliance and may be asked by the auditor EXCEPT:
1 Where are the records and SOPs that apply when receiving primary packaging materials?
2 Show me the approved specification and current QC results for a material used in production.
3 Show me the observations from the last self-inspection.
4 Show me the calibration and maintenance records for the packaging line.
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GLOBAL ANSWER 13
A regulatory professional at a pharmaceutical manufacturing facility is training the production staff on

what questions to expect during an upcoming PIC/S audit. All of the following cover critical aspects of GMP
compliance and may be asked by the auditor EXCEPT:
1 Where are the records and SOPs that apply when receiving primary packaging materials?
2 Show me the approved specification and current QC results for a material used in production.
3 Show me the observations from the last self-inspection.
4 Show me the calibration and maintenance records for the packaging line.
PIC/S, Aide-Memoire on Packaging PI 028-1 (13 January 2009). An inspector can ask to be shown the self-inspection plan and outcome, but not
the actual observations of a self-inspection
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GLOBAL QUESTION 14
Company ABC is sponsoring an ongoing multi-center clinical trial for a product intended for children. Dr.
Smith has been qualified and selected as one of the investigators in this clinical trial. In compliance with
Good Clinical Practice, Dr. Smith must do all of the following to enroll a subject EXCEPT:
1 Obtain and document informed consent from a legally acceptable representative
2 Obtain an approval from the IRB/IEC
3 Explain the trial to the extent compatible with the subject’s understanding and obtain assent from the
subject, if capable
4 Obtain a signed informed consent from Company ABC
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GLOBAL ANSWER 14
Company ABC is sponsoring an ongoing multi-center clinical trial for a product intended for children. Dr.
Smith has been qualified and selected as one of the investigators in this clinical trial. In compliance with
Good Clinical Practice, Dr. Smith must do all of the following to enroll a subject EXCEPT:
1 Obtain and document informed consent from a legally acceptable representative
2 Obtain an approval from the IRB/IEC
3 Explain the trial to the extent compatible with the subject’s understanding and obtain assent from the
subject, if capable
4 Obtain a signed informed consent from Company ABC
ICH E6, Guideline for Good Clinical Practice. Prior to a subject’s participation in the trial, the written informed consent form should be signed
and personally dated by the subject or by the subject's legally acceptable representative. The investigator should have the IRB/IEC's written
approval/favorable opinion of the written informed consent. Both the informed consent discussion and the written informed consent form and any
29 other written information to be provided to subjects should include explanations.
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GLOBAL QUESTION 15
Orphan product designation

1 Is based on a disease or condition’s incidence or prevalence in a country or region
2 Does not provide market exclusivity except in the US or EU
3 Provides expedited reviews in all ICH participant countries
4 Is only available for products supported through special grant funding in Australia
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GLOBAL ANSWER 15
Orphan product designation

1 Is based on a disease or condition’s incidence or prevalence in a country or region
2 Does not provide market exclusivity except in the US or EU
3 Provides expedited reviews in all ICH participant countries
4 Is only available for products supported through special grant funding in Australia
US Orphan Drug Act provides seven years of market exclusivity and EU Regulation provides 10 years of
exclusivity. EU countries do not provide expedited reviews. Centralised Procedure is used for orphan drug.
Australia Orphan Drug Program does not provide research grants.
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GLOBAL QUESTION 16
Prior to first human exposure, single-dose (acute) toxicity should be evaluated in:
1 One rodent and one mammalian species
2 Two mammalian species
3 Two rodent species
4 One rodent species
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GLOBAL ANSWER 16
Prior to first human exposure, single-dose (acute) toxicity should be evaluated in:
1 One rodent and one mammalian species
2 Two mammalian species
3 Two rodent species
4 One rodent species
ICH M3(R2), Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals, June 2009. Historically, acute toxicity information has been obtained from single-dose toxicity studies in two
mammalian species using both the clinical trial and a parenteral route of administration.
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GLOBAL QUESTION 17
A small contract laboratory is conducting nonclinical health and environmental safety studies that include
planning, performing, monitoring, recording, reporting and archiving for a large pharmaceutical company.
The quality system concerned with the organizational process and conditions is:
1 Good Laboratory Practices (GLP)

2 Good Manufacturing Practices (GMP)
3 Good Clinical Practices (GCP)
4 GLPs and GCPs
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GLOBAL ANSWER 17
A small contract laboratory is conducting nonclinical health and environmental safety studies that include
planning, performing, monitoring, recording, reporting and archiving for a large pharmaceutical company.
The quality system concerned with the organizational process and conditions is:
1 Good Laboratory Practices (GLP)

2 Good Manufacturing Practices (GMP)
3 Good Clinical Practices (GCP)
4 GLPs and GCPs
Organisation for Economic Co-operation and Development (OECD) Series on Principles of Good Laboratory Practice (GLP) and Compliance
Monitoring, No. 1, ENV/MC/CHEM(98)17, 1997. Good Laboratory Practice (GLP) is a quality system concerned with the organizational process
and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived and
reported.
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GLOBAL QUESTION 18
The date of a medicinal product’s first marketing authorization granted to the marketing authorization
holder in any country in the world determines the data-lock point for purposes of the unified Periodic
Benefit-Risk Evaluation Report (PBRER) (previously the Periodic Safety Update Report (PSUR)) is known as:
1 European birth date
2 International birth date
3 US approval date
4 Canadian approval date
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GLOBAL ANSWER 18
The date of a medicinal product’s first marketing authorization granted to the marketing authorization
holder in any country in the world determines the data-lock point for purposes of the unified Periodic
Benefit-Risk Evaluation Report (PBRER) (previously the Periodic Safety Update Report (PSUR)) is known as:
1 European birth date
2 International birth date
3 US approval date
4 Canadian approval date
ICH E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), December 2012. International Birth Date (IBD), the date of the first marketing
authorization for the product granted to any company in any country in the world.
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GLOBAL QUESTION 19
The US, EU and Japan initiated the ICH process to address various inconsistencies in pharmaceutical product
registration requirements. ICH addresses all of the following EXCEPT:
1 Product stability and storage condition studies

2 Drug substance and drug product analytical method validation
3 Drug adverse event reporting system
4 Chemical and drug patent issues
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GLOBAL ANSWER 19
The US, EU and Japan initiated the ICH process to address various inconsistencies in pharmaceutical product
registration requirements. ICH addresses all of the following EXCEPT:
1 Product stability and storage condition studies

2 Drug substance and drug product analytical method validation
3 Drug adverse event reporting system
4 Chemical and drug patent issues
ICH Q1A(R2), Stability Testing of New Drug Substances and Products, February 2003
ICH Q2(R1), Validation of Analytical Procedures: Text and Methodology, November 1996
ICH E2B(R2), Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports,
February 2001
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GLOBAL QUESTION 20
What criteria should be used to define the animal species used for preclinical toxicity testing for a
biotechnology product?
1 Target receptor and/or epitope distribution

2 Biological activity with species and/or tissue specificity
3 Immunochemical and functional tests
4 Proposed product route and frequency of administration
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GLOBAL ANSWER 20
What criteria should be used to define the animal species used for preclinical toxicity testing for a
biotechnology product?
1 Target receptor and/or epitope distribution

2 Biological activity with species and/or tissue specificity
3 Immunochemical and functional tests
4 Proposed product route and frequency of administration
ICH S6(R1), Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, June 2011. Due to the species specificity of many
biotechnology-derived pharmaceuticals, it is important to select relevant animal species for toxicity testing. The biological activity together with
species and/or the drug’s tissue specificity should be considered.
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GLOBAL QUESTION 21
What routine documents must a pharmacovigilance plan include?

1 Monitoring reports
2 Adverse event (AE) standard operating procedures (SOPs)
3 Adverse drug reactions (ADRs) and periodic safety update reports (PSURs)
4 ADRs and AEs
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GLOBAL ANSWER 21
What routine documents must a pharmacovigilance plan include?

1 Monitoring reports
2 Adverse event (AE) standard operating procedures (SOPs)
3 Adverse drug reactions (ADRs) and periodic safety update reports (PSURs)
4 ADRs and AEs
ICH E2E, Pharmacovigilance Planning, November 2004. 3.1.2 Routine Pharmacovigilance Practices: Expedited adverse drug
reaction(ADR) reports and Periodic Safety Update Reports (PSURs)
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GLOBAL QUESTION 22
A regulatory authority has requested some additional nonclinical testing on your product prior to final
approval, but it has assured you the product will be approved when testing is completed. Senior
management wants to begin production while this testing is being conducted. What should you recommend
to your senior management?
1 Support the management decision to begin production prior to final approval
2 Advise management it is better to wait for final approval as the regulatory authority may request some
changes that will affect production
3 Inform stakeholders about product development pitfalls that are preventing production from beginning
4 Submit a request to the regulatory authority for a rapid turnaround of the final review and approval
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GLOBAL ANSWER 22
A regulatory authority has requested some additional nonclinical testing on your product prior to final
approval, but it has assured you the product will be approved when testing is completed. Senior
management wants to begin production while this testing is being conducted. What should you recommend
to your senior management?
1 Support the management decision to begin production prior to final approval
2 Advise management it is better to wait for final approval as the regulatory authority may request some
changes that will affect production
3 Inform stakeholders about product development pitfalls that are preventing production from beginning
4 Submit a request to the regulatory authority for a rapid turnaround of the final review and approval
Since there is a concern by the authority driving the request for nonclinical studies, there is a possibility of a product/
production change. Advise management of the amount of time required for nonclinical testing and the potential risk for
approval delay or disapproval that may result in changes affecting production.
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GLOBAL QUESTION 23
Which of the following is NOT required for reporting a serious adverse event?
1 An identifiable patient name
2 An identifiable event or outcome
3 An identifiable reporting source
4 An identifiable medicinal product
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GLOBAL ANSWER 23
Which of the following is NOT required for reporting a serious adverse event?
1 An identifiable patient name
2 An identifiable event or outcome
3 An identifiable reporting source
4 An identifiable medicinal product
ICH E2A, Clinical Safety Data Management: Definitions And Standards For Expedited Reporting, October 1994. According to GCP, patient
names should not be included in CRF, AE and SAE reports. GCP 4.11 Safety Reporting: The immediate and follow-up reports should identify
subjects by unique code numbers assigned to the trial subjects rather than by the subjects’ names, personal identification numbers and/or
address.
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GLOBAL QUESTION 24
Which of the following situations does not require rapid communication to regulatory authorities?
1 A clinically important increase in the rate of occurrence of expected, serious ADRs
2 A lack of efficacy for a medicinal product used to treat a life-threatening disease
3 A statistically significant increase in the number of animal deaths in a dose finding study
4 A major safety finding from a newly completed animal carcinogenicity study
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GLOBAL ANSWER 24
Which of the following situations does not require rapid communication to regulatory authorities?
1 A clinically important increase in the rate of occurrence of expected, serious ADRs
2 A lack of efficacy for a medicinal product used to treat a life-threatening disease
3 A statistically significant increase in the number of animal deaths in a dose finding study
4 A major safety finding from a newly completed animal carcinogenicity study
ICH E2A Clinical Safety Data Management: Definitions And Standards For Expedited Reporting, October 1994. There are situations in addition to
single case reports of "serious" adverse events or reactions that may necessitate rapid communication to regulatory authorities; appropriate medical
and scientific judgment should be applied for each situation. In general, information that might influence a medicinal product’s benefit-risk assessment
materially product or would be sufficient to consider changes in medicinal product administration or the overall conduct of a clinical investigation
represents such situations. Examples include:
• a. For an "expected," serious ADR, an increase in the rate of occurrence judged to be clinically important.
• b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease.
• c. A major safety finding from a newly completed animal study (such as carcinogenicity).
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GLOBAL QUESTION 25
Which of the following statements about biosimilars is NOT correct?

1 Biosimilars will not be substituted for innovator products
2 Biosimilars are considered as generic pharmaceuticals and use the same marketing review procedures
3 Similar products are considered for well-characterized single protein products but not currently for
vaccines
4 In some countries/regions, biosimilars may be approved based on less data than required for a
completely new biologic product
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GLOBAL ANSWER 25
Which of the following statements about biosimilars is NOT correct?

1 Biosimilars will not be substituted for innovator products
2 Biosimilars are considered as generic pharmaceuticals and use the same marketing review procedures
3 Similar products are considered for well-characterized single protein products but not currently for
vaccines
4 In some countries/regions, biosimilars may be approved based on less data than required for a
completely new biologic product
Biotherapeutics and Biosimilars. (WHO Drug Information Vol. 29, No. 2, 2015). Biosimilars are not under the same review
procedure as generic drugs.
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GLOBAL QUESTION 26
Which of the following statements is true about implementing Quality by Design principles, as defined in
ICH Q8(R2) Pharmaceutical Development?
1 Implementing QbD is only applicable to development and registration of new medicinal products. Existing
commercial products are excluded from the scope.
2 Implementing QbD eliminates the need for finished product testing.
3 GMPs are not required for batches of drug product manufactured using QbD principles.
4 QbD is an enhanced approach encouraged by regulators, but not mandatory.
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GLOBAL ANSWER 26
Which of the following statements is true about implementing Quality by Design principles, as defined in
ICH Q8(R2) Pharmaceutical Development?
1 Implementing QbD is only applicable to development and registration of new medicinal products. Existing
commercial products are excluded from the scope.
2 Implementing QbD eliminates the need for finished product testing.
3 GMPs are not required for batches of drug product manufactured using QbD principles.
4 QbD is an enhanced approach encouraged by regulators, but not mandatory.
ICH Q8(R2) Pharmaceutical Development, August 2009. EMEA/CHMP/ICH/265145/2009 Note for guidance on Pharmaceutical Development
Quality Risk Management Pharmaceutical Quality System
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GLOBAL QUESTION 27
Which of the following is NOT a benefit of implementing a Pharmaceutical Quality System (PQS) in
accordance with ICH Q10?
1 The PQS can be certified through the ICH Q10 Certification Program, reducing the frequency of
inspections.
2 Robustness of the manufacturing process and continuous improvement are facilitated through science and
risk-based postapproval change processes
3 Reduces risk of product failure and incidence of complaints and recalls
4 The PQS provides an opportunity to increase understanding between industry and regulators and more
optimal use of industry and regulator resources
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GLOBAL ANSWER 27
Which of the following is NOT a benefit of implementing a Pharmaceutical Quality System (PQS) in
accordance with ICH Q10?
1 The PQS can be certified through the ICH Q10 Certification Program, reducing the frequency of
inspections.
2 Robustness of the manufacturing process and continuous improvement are facilitated through science and
risk-based postapproval change processes
3 Reduces risk of product failure and incidence of complaints and recalls
4 The PQS provides an opportunity to increase understanding between industry and regulators and more
optimal use of industry and regulator resources
ICH Q10, Pharmaceutical Quality System, June 2008
EMEA/CHMP/ICH/265145/2009 Note for guidance on Pharmaceutical Development Quality Risk Management Pharmaceutical Quality
System Questions and Answers
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GLOBAL QUESTION 28
According to the ICH Good Clinical Practice (GCP) guidelines, all of the following are considered essential
documents for the conduct of a clinical trial EXCEPT:
1 Subject enrollment log
2 Signed Informed Consent Forms
3 Investigator’s brochure
4 Audit reports
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GLOBAL ANSWER 28
According to the ICH Good Clinical Practice (GCP) guidelines, all of the following are considered essential
documents for the conduct of a clinical trial EXCEPT:
1 Subject enrollment log
2 Signed Informed Consent Forms
3 Investigator’s brochure
4 Audit reports
ICH E8, General Considerations for Clinical Trials, July 1997 and ICH M3(R2), Guidance on Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, June 2009. An audit report is not
considered an essential document. An audit certificate, however, is an essential document.
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GLOBAL QUESTION 29
The party responsible for the proper constitution (membership) of the Independent Ethics
Committee/Institutional Review Board and the authority under which it is established is the:
1 Sponsor
2 Study monitor
3 Principal investigator
4 Independent Ethics Committee/Institutional Review Board
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GLOBAL ANSWER 29
The party responsible for the proper constitution (membership) of the Independent Ethics
Committee/Institutional Review Board and the authority under which it is established is the:
1 Sponsor
2 Study monitor
3 Principal investigator
4 Independent Ethics Committee/Institutional Review Board
ICH E6(R1), Good Clinical Practice, June 1996 and 21 CFR 56.107 IRB Membership
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GLOBAL QUESTION 30
The following statements regarding the Informed Consent Form (ICF) are true, EXCEPT:
1 The ICF is approved by the IRB/IEC prior to the beginning of the trial and is revised whenever important
new information becomes available that may be relevant to the subjects’ consent
2 The ICF must inform subjects of the nature, significant implications and risks of the trial in language that is
understandable to the subjects
3 The ICF is signed and dated by the subject or his representative and a copy of the signed and dated form
should be received by the subject or his representative prior to the beginning of the trial
4 The signed ICF does not allow for the withdrawal of the subject from the study until the required data has
been obtained
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GLOBAL ANSWER 30
The following statements regarding the Informed Consent Form (ICF) are true, EXCEPT:
1 The ICF is approved by the IRB/IEC prior to the beginning of the trial and is revised whenever important
new information becomes available that may be relevant to the subjects’ consent
2 The ICF must inform subjects of the nature, significant implications and risks of the trial in language that is
understandable to the subjects
3 The ICF is signed and dated by the subject or his representative and a copy of the signed and dated form
should be received by the subject or his representative prior to the beginning of the trial
4 The signed ICF does not allow for the withdrawal of the subject from the study until the required data has
been obtained
See ICH E6, Good Clinical Practice, June 1996, Section 4.8, Informed consent of trial subjects.
Question Feedback
ICH E6 p.17 (m) states the subject’s participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which
the subject otherwise is entitled.
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GLOBAL QUESTION 31
Which of the following is NOT a requirement for an IRB/IEC?

1 All members of the IRB/IEC should be associated with the institution where the trial is being conducted
2 The IRB/IEC meeting schedule should be published, and minutes of the meeting must be maintained
3 Have written procedures requiring that the IRB/IEC promptly notify the investigator, in writing, of the
procedures for appeal of its decisions/opinions
4 The IRB/IEC should provide copies of its written procedures and membership lists when requested by a
sponsor
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GLOBAL ANSWER 31
Which of the following is NOT a requirement for an IRB/IEC?

1 All members of the IRB/IEC should be associated with the institution where the trial is being conducted
2 The IRB/IEC meeting schedule should be published, and minutes of the meeting must be maintained
3 Have written procedures requiring that the IRB/IEC promptly notify the investigator, in writing, of the
procedures for appeal of its decisions/opinions
4 The IRB/IEC should provide copies of its written procedures and membership lists when requested by a
sponsor
ICH E6, Good Clinical Practice, June 1996

21 CFR 56.107 IRB Membership
Question Feedback
Per 21 CFR 56.107, “Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the
institution.”
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GLOBAL QUESTION 32
Which statement of the cooperative manufacturing arrangements for US-licensed biologics is NOT true?
1 The short supply provisions may be used by licensed manufacturers to obtain initial and partially
manufactured materials from an unlicensed facility.
2 Contract manufacturing involves a licensee contracting out one or more manufacturing steps.
3 Shared manufacturing involves multiple licensed manufacturers, each of which performs significant
manufacturing steps in the production of one product.
4 For divided manufacturing, a sponsor needs to obtain a separate Biologics License Application for
each contract manufacturer or utilize a Drug Master File in the US.
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GLOBAL ANSWER 32
Which statement of the cooperative manufacturing arrangements for US-licensed biologics is NOT true?
1 The short supply provisions may be used by licensed manufacturers to obtain initial and partially
manufactured materials from an unlicensed facility.
2 Contract manufacturing involves a licensee contracting out one or more manufacturing steps.
3 Shared manufacturing involves multiple licensed manufacturers, each of which performs significant
manufacturing steps in the production of one product.
4 For divided manufacturing, a sponsor needs to obtain a separate Biologics License Application for
each contract manufacturer or utilize a Drug Master File in the US.
FDA Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, November 2008
Question Feedback
Divided manufacturing involves the joint production of a biologics product by multiple manufacturers, each of which is licensed to manufacture the entire product. A sponsor does not need to obtain a
separate BLA for each contract manufacturer. The sponsor can utilize a DMF in the US.
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GLOBAL QUESTION 33
For a biologics product, the following postapproval changes may be assessed as reportable annually
EXCEPT:
1 Tightening of specifications for existing reference standards to provide greater assurance of
product purity, identity, and potency.
2 Modifications to an existing HVAC system that supplies aseptic processing areas.
3 Changes in the layout of the container label without a change in content of the labeling.
4 Addition of time points to the stability protocol.
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GLOBAL ANSWER 33
For a biologics product, the following postapproval changes may be assessed as reportable annually
EXCEPT:
1 Tightening of specifications for existing reference standards to provide greater assurance of
product purity, identity, and potency.
2 Modifications to an existing HVAC system that supplies aseptic processing areas.
3 Changes in the layout of the container label without a change in content of the labeling.
4 Addition of time points to the stability protocol.
FDA Guidance for Industry: Changes to an Approved Application: Biological Products, July 1997
Question Feedback
Installation of HVAC is considered major construction, which involves and affects environmentally controlled manufacturing or related support areas.
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GLOBAL QUESTION 34
Which of the following pharmaceutical dosage forms generally is considered to have the LEAST risk of
interaction between packaging components and dosage form?
1 An oral (soft gelatin) capsule
2 A transdermal patch
3 An ophthalmic suspension
4 An inhalation aerosol
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GLOBAL ANSWER 34
Which of the following pharmaceutical dosage forms generally is considered to have the LEAST risk of
interaction between packaging components and dosage form?
1 An oral (soft gelatin) capsule
2 A transdermal patch
3 An ophthalmic suspension
4 An inhalation aerosol
FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, May 1999
Question Feedback
According to the guidance, p. 6, Table 1, Examples of packaging concerns for common classes of drug product, oral tablets and capsules are
at the lowest risk for interaction with packaging material.
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GLOBAL QUESTION 35
For a biologics product, the following strategies are appropriate for submission of a comparability protocol
EXCEPT:
1 Submit as part of an original market application.
2 Submit in a Prior Approval Supplement that consists only of the proposed comparability protocol, prior
to generating data specified in the protocol.
3 Submit in a Prior Approval Supplement that includes the proposed comparability protocol, study results
and any other pertinent information as specified in the proposed comparability protocol.
4 Submit in the Annual Report, accompanied with study results.
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GLOBAL ANSWER 35
For a biologics product, the following strategies are appropriate for submission of a comparability protocol
EXCEPT:
1 Submit as part of an original market application.
2 Submit in a Prior Approval Supplement that consists only of the proposed comparability protocol, prior
to generating data specified in the protocol.
3 Submit in a Prior Approval Supplement that includes the proposed comparability protocol, study results
and any other pertinent information as specified in the proposed comparability protocol.
4 Submit in the Annual Report, accompanied with study results.
ICH Q5c, Q6B, Q11
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GLOBAL QUESTION 36
Which of the following is NOT an element of the ICH Common Technical Document (CTD) Module 4 (Non-
clinical study reports)?
1 Pharmacodynamic drug interactions
2 Genotoxicity
3 Bioavailability (BA)
4 Carcinogenicity
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GLOBAL ANSWER 36
Which of the following is NOT an element of the ICH Common Technical Document (CTD) Module 4 (Non-
clinical study reports)?
1 Pharmacodynamic drug interactions
2 Genotoxicity
3 Bioavailability (BA)
4 Carcinogenicity
ICH CTD M4 guides. Bioavailability (BA) Study Reports are included in Module 5 (Clinical study report).
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GLOBAL QUESTION 37
Your company is outsourcing the manufacturing of a biologic bulk drug to a contract manufacturing
organization (CMO). The drug substance will be used for toxicology studies and first-in-human (FIH) clinical
trials. Your company should ask the CMO to perform which of the following tasks?
1 Validate the equipment and process prior to manufacturing the supplies.

2 Document clinical bulk drug manufacturing in laboratory notebooks or batch records.
3 Investigate yield variation of batches produced.
4 Conduct comparability bridging study between research batches made by your company and batches
made by the CMO.
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GLOBAL ANSWER 37
Your company is outsourcing the manufacturing of a biologic bulk drug to a contract manufacturing
organization (CMO). The drug substance will be used for toxicology studies and first-in-human (FIH) clinical
trials. Your company should ask the CMO to perform which of the following tasks?
1 Validate the equipment and process prior to manufacturing the supplies.

2 Document clinical bulk drug manufacturing in laboratory notebooks or batch records.
3 Investigate yield variation of batches produced.
4 Conduct comparability bridging study between research batches made by your company and batches
made by the CMO.
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (November 2000) and ICH Q5E Comparability of
Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (November 2004). “The production of APIs for use in
clinical trials should be documented in laboratory notebooks, batch records” “Expected yields can be more variable and less defined than the
expected yields used in commercial process. Investigations of yield variation are not expected.” “Process validation for the production of APIs
75 used in clinical trials is normally inappropriate.”
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GLOBAL QUESTION 38
Your company is preparing a standard battery of toxicology studies to evaluate a biological drug
candidate’s safety. The following tests should be included in the studies, EXCEPT:
1 Single dose toxicity study
2 Repeated dose toxicity study
3 Immunotoxicity study
4 Genotoxicity study
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GLOBAL ANSWER 38
Your company is preparing a standard battery of toxicology studies to evaluate a biological drug
candidate’s safety. The following tests should be included in the studies, EXCEPT:
1 Single dose toxicity study
2 Repeated dose toxicity study
3 Immunotoxicity study
4 Genotoxicity study
ICH S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (1997). ICH S6(R1) p.8, “The range and type of genotoxicity
studies routinely conducted for pharmaceuticals are not applicable to biotechnology-derived pharmaceuticals and therefore are not needed.”
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GLOBAL QUESTION 39
All of the following statements are true for thresholds for degradation products in new drug products
EXCEPT:
1 Thresholds for degradation products are expressed as either a percentage of the drug substance or total
daily intake (TDI) of the degradation product.
2 Thresholds include qualification thresholds and identification thresholds.
3 Lower thresholds can be appropriate if the degradation product is unusually toxic.
4 Higher thresholds should be scientifically justified.
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GLOBAL ANSWER 39
All of the following statements are true for thresholds for degradation products in new drug products
EXCEPT:
1 Thresholds for degradation products are expressed as either a percentage of the drug substance or total
daily intake (TDI) of the degradation product.
2 Thresholds include qualification thresholds and identification thresholds.
3 Lower thresholds can be appropriate if the degradation product is unusually toxic.
4 Higher thresholds should be scientifically justified.
ICH Q3B(R2) Impurities in New Drug Products (June 2006). Thresholds for degradation products in new drug products include reporting thresholds, qualification
thresholds and identification thresholds.
 Reporting Threshold: A limit above which a degradation product should be reported.
 Qualification Threshold: A limit above which a degradation product should be qualified.
 Identification Threshold: A limit above which a degradation product should be identified.
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GLOBAL QUESTION 40
A company is planning to market a new drug (Drug A) globally. Drug A’s safety, efficacy and dosing, as
well as its use in special populations, have been addressed in Region X. To demonstrate the safety, efficacy
and dosing information from Region X are relevant to other regions with different medical settings, Drug
A’s property that would make it less likely to be sensitive to ethnic factors is:
1 Metabolism distributed through single pathway
2 Low bioavailability, thus, less susceptibility to dietary absorption
3 Flat pharmacodynamic (PD) (effect-concentration) curve for both efficacy and safety in the range of the
recommended dosage and dose regimen’s effects
4 Administration as a prodrug
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GLOBAL ANSWER 40
A company is planning to market a new drug (Drug A) globally. Drug A’s safety, efficacy and dosing, as
well as its use in special populations, have been addressed in Region X. To demonstrate the safety, efficacy
and dosing information from Region X are relevant to other regions with different medical settings, Drug
A’s property that would make it less likely to be sensitive to ethnic factors is:
1 Metabolism distributed through single pathway
2 Low bioavailability, thus, less susceptibility to dietary absorption
3 Flat pharmacodynamic (PD) (effect-concentration) curve for both efficacy and safety in the range of the
recommended dosage and dose regimen’s effects
4 Administration as a prodrug
ICH E5 (R1) factors in the Acceptability of Foreign Clinical Data
The following properties of a compound make it less likely to be sensitive to ethnic factors:
 Linear pharmacokinetics (pK)
 A flat pharmacodynamic (PD) (effect-concentration) curve for both efficacy and safety in the range of the recommended dosage and dose regimen (this may mean that the medicine is well-
tolerated)
 A wide therapeutic dose range (again, possibly an indicator of good tolerability)
 Minimal metabolism or metabolism distributed among multiple pathways
 High bioavailability, thus less susceptibility to dietary absorption effects
 Low potential for protein binding
 Little potential for drug-drug, drug-diet and drug-disease interactions
 Non-systemic mode of action
81  Little potential for inappropriate use
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GLOBAL QUESTION 41
Drug Y is a newly launched product with one strength but marketed in different commercial packs. The bulk
product is manufactured and stored for a period before being packaged into blister or bottle packs. Your
company is about to initiate the ongoing stability program for Drug Y. A written protocol has been put in
place, but the production department raised concern about the bulk product’s stability. What is the BEST course
of action?
1 Start the ongoing stability program as planned
2 Shorten the testing frequency in the ongoing stability program
3 Include additional batches in the ongoing stability program
4 Include the bulk product in the ongoing stability program to evaluate and study the impact on the stability of
the packaged product
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GLOBAL ANSWER 41
Drug Y is a newly launched product with one strength but marketed in different commercial packs. The bulk
product is manufactured and stored for a period before being packaged into blister or bottle packs. Your
company is about to initiate the ongoing stability program for Drug Y. A written protocol has been put in
place, but the production department raised concern about the bulk product’s stability. What is the BEST course
of action?
1 Start the ongoing stability program as planned
2 Shorten the testing frequency in the ongoing stability program
3 Include additional batches in the ongoing stability program
4 Include the bulk product in the ongoing stability program to evaluate and study the impact on the stability of
the packaged product
PIC/S GMP Guide PE 009-10 (Part I: Basic Requirement for Medicinal Products)
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GLOBAL QUESTION 42
You are the regulatory manager for a company with a pipeline of biological products. The team is planning
a series of preclinical studies for one product. However, due to a limited budget, only some of the following
studies can be performed in compliance with Good Laboratory Practice (GLP). Which of the following
studies are NOT expected to be conducted under GLP?
1 Pharmacodynamic studies
2 Single dose toxicity studies
3 Repeated dose toxicity studies
4 Immunotoxicity studies
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GLOBAL ANSWER 42
You are the regulatory manager for a company with a pipeline of biological products. The team is planning
a series of preclinical studies for one product. However, due to a limited budget, only some of the following
studies can be performed in compliance with Good Laboratory Practice (GLP). Which of the following
studies are NOT expected to be conducted under GLP?
1 Pharmacodynamic studies
2 Single dose toxicity studies
3 Repeated dose toxicity studies
4 Immunotoxicity studies
ICH S6 (R1) (September 1997) Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals, “Toxicity studies are expected to be
performed in compliance with Good Laboratory Practice (GLP); however, it is recognised that some studies employing specialised test systems
which are often needed for biopharmaceuticals, may not be able to comply fully with GLP.” Pharmacodynamic studies are not required to be
conducted under GLP, but all toxicity studies are.
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GLOBAL QUESTION 43
According to Good Clinical Practice, which of the following documents are NOT supposed to be kept in the
sponsor’s Trial Master Files during the conduct of the clinical trial?
1 Regulatory authority approval of protocol
2 Signed informed consent forms
3 Investigator’s Brochure
4 Dated, documented approval of IRB/IEC of the protocol
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GLOBAL ANSWER 43
According to Good Clinical Practice, which of the following documents are NOT supposed to be kept in the
sponsor’s Trial Master Files during the conduct of the clinical trial?
1 Regulatory authority approval of protocol
2 Signed informed consent forms
3 Investigator’s Brochure
4 Dated, documented approval of IRB/IEC of the protocol
ICH E6(R1) (May 1996) Good Clinical Practice, pages 42–51. Signed inform consent forms should be kept by the investigator at the study site
during the conduct of the clinical trial.
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GLOBAL QUESTION 44
A regulatory professional is reviewing documents on producing a human recombinant protein with a

mammalian cell line at a manufacturing facility. All of the following are required to be in compliance with
Good Manufacturing Practice (GMP) EXCEPT:
1 Establishing a master cell bank
2 Maintenance of working cell bank
3 Isolation and purification of recombinant proteins
4 Packaging of drug products
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GLOBAL ANSWER 44
A regulatory professional is reviewing documents on producing a human recombinant protein with a

mammalian cell line at a manufacturing facility. All of the following are required to be in compliance with
Good Manufacturing Practice (GMP) EXCEPT:
1 Establishing a master cell bank
2 Maintenance of working cell bank
3 Isolation and purification of recombinant proteins
4 Packaging of drug products
ICH Q7 (February 1998) Good Manufacturing Practice for Active Pharmaceutical Ingredients, p.3. For biotechnological products, GMP applies
to manufacturing processes starting from maintenance of the working cell bank. It does not apply to establishment of a master cell bank and
working cell bank.
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GLOBAL QUESTION 45
The correct sequence of risk management activities is:

1 (1) risk analysis, (2) risk evaluation, (3) establish acceptability criteria, (4) risk control
2 (1) establish acceptability criteria, (2) risk analysis, (3) risk evaluation, (4) risk control
3 (1) establish acceptability criteria, (2) risk evaluation, (3) risk analysis, (4) risk control
4 (1) risk analysis, (2) establish acceptability criteria, (3) risk evaluation, (4) risk control
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GLOBAL ANSWER 45
The correct sequence of risk management activities is:

1 (1) risk analysis, (2) risk evaluation, (3) establish acceptability criteria, (4) risk control
2 (1) establish acceptability criteria, (2) risk analysis, (3) risk evaluation, (4) risk control
3 (1) establish acceptability criteria, (2) risk evaluation, (3) risk analysis, (4) risk control
4 (1) risk analysis, (2) establish acceptability criteria, (3) risk evaluation, (4) risk control
ICH Q9 Quality Risk Management. Risk evaluation compares the identified and analyzed risk against given risk criteria and
risk control is a response to the evaluation.
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GLOBAL QUESTION 46
You learn your company’s marketing department is planning a global direct-to-consumer (DTC) advertising
campaign to launch your latest biologic product. Since your company policies are based on WHO directives
and recommendations, you should:
1 Request a copy of the advertisement for your files
2 Verify the advertisement is based on valid scientific and clinical evidence representing populations in the
countries where the advertisement will be used
3 Ensure the advertisement includes a comparison to other medicines of a similar nature
4 Notify the marketing department that the DTC advertising is not allowed
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GLOBAL ANSWER 46
You learn your company’s marketing department is planning a global direct-to-consumer (DTC) advertising
campaign to launch your latest biologic product. Since your company policies are based on WHO directives
and recommendations, you should:
1 Request a copy of the advertisement for your files
2 Verify the advertisement is based on valid scientific and clinical evidence representing populations in the
countries where the advertisement will be used
3 Ensure the advertisement includes a comparison to other medicines of a similar nature
4 Notify the marketing department that the DTC advertising is not allowed
WHO Resolution WHAA 41.17 Ethical Criteria for Medicinal Drug Promotion 1988
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GLOBAL QUESTION 47
You are responsible for implementing a pharmaceutical quality system in a small start-up company. Which
of the following is NOT an element of a pharmaceutical quality system?
1 Corrective action and preventive action (CAPA) system
2 Change management system
3 PSUR and ADR reporting
4 Management review of process performance and product quality
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GLOBAL ANSWER 47
You are responsible for implementing a pharmaceutical quality system in a small start-up company. Which
of the following is NOT an element of a pharmaceutical quality system?
1 Corrective action and preventive action (CAPA) system
2 Change management system
3 PSUR and ADR reporting
4 Management review of process performance and product quality
ICH Q10 Pharmaceutical Quality System Elements—the elements described below might be, required in part under regional GMP regulations. However, the Q10
model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality.
 process performance and product quality monitoring system
 corrective action and preventive action (CAPA) system
 change management system
 management review of process performance and product quality
These elements should be applied in an appropriate and proportionate manner in each product lifecycle stage, recognizing the differences among, and the different
goals of, each stage.
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GLOBAL QUESTION 48
US company A is going to conduct a Phase 3 study in country X. As company A’s regulatory professional,
the action you should take is:
1 Clarify country X regulations for clinical trial studies
2 Guarantee the clinical study follows GCP and the study result could be accepted by FDA
3 Work with country X’s regulatory team for testing drug preparation, transportation and custom clearance
4 Obtain local IRB/IEC approval letter from country X
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GLOBAL ANSWER 48
US company A is going to conduct a Phase 3 study in country X. As company A’s regulatory professional,
the action you should take is:
1 Clarify country X regulations for clinical trial studies
2 Guarantee the clinical study follows GCP and the study result could be accepted by FDA
3 Work with country X’s regulatory team for testing drug preparation, transportation and custom clearance
4 Obtain local IRB/IEC approval letter from country X
Regulatory professionals could help finish answers 2, 3 and 4, but they are not the first priority.
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GLOBAL QUESTION 49
According to ICH Q5C,when planning a biological product stability program for market authorization, all of
the following requirements should be considered, EXCEPT:
1 Selection of at least three representative batches
2 Minimum of three months of stability data at the time of submission
3 When the product is to be marketed in different strengths or in different size containers, the sample size to
be tested can be reduced based on matrixing and/or bracketing
4 When shelf-lives of one year or less are proposed, the real-time stability studies should be conducted
monthly for the first three months and at three-month intervals thereafter
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GLOBAL ANSWER 49
According to ICH Q5C,when planning a biological product stability program for market authorization, all of
the following requirements should be considered, EXCEPT:
1 Selection of at least three representative batches
2 Minimum of three months of stability data at the time of submission
3 When the product is to be marketed in different strengths or in different size containers, the sample size to
be tested can be reduced based on matrixing and/or bracketing
4 When shelf-lives of one year or less are proposed, the real-time stability studies should be conducted
monthly for the first three months and at three-month intervals thereafter
Regulatory Reference: ICH Q5C, Stability testing of Biotechnological/Biological Products, 1995. Stability information should be provided on at
least three batches of final container product representative ... A minimum of six months data at the time of submission.
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99
GLOBAL QUESTION 50
You are advising your company’s senior managers on a chemistry, manufacturing and controls (CMC)
regulatory compliance strategy for a new biotech product. Your advice includes all of the following EXCEPT:
1 Emphasize senior management has ultimate responsibility for regulatory compliance
2 Meet with regulatory authorities before initiating Phase 1 trial to prevent clinical hold
3 Avoid manufacturing process change after obtaining market approval
4 Apply Quality by Design (QbD) to product development to gain regulatory flexibility
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GLOBAL ANSWER 50
You are advising your company’s senior managers on a chemistry, manufacturing and controls (CMC)
regulatory compliance strategy for a new biotech product. Your advice includes all of the following EXCEPT:
1 Emphasize senior management has ultimate responsibility for regulatory compliance
2 Meet with regulatory authorities before initiating Phase 1 trial to prevent clinical hold
3 Avoid manufacturing process change after obtaining market approval
4 Apply Quality by Design (QbD) to product development to gain regulatory flexibility
ICH Q10, p. 4, 2.1 Management Commitment
(a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles,
responsibilities and authorities are defined, communicated and implemented throughout the company.
The pre-IND meeting can be very valuable in planning a drug development program, especially if sponsors' questions are not fully answered by guidances and other
information provided by FDA. Early interactions with FDA staff can help prevent clinical hold issues from arising.
ICH Q10, p. 7, 3.1.3 Commercial Manufacturing
The goals of manufacturing activities include achieving product realisation, establishing and maintaining a state of control and facilitating continual improvement. (Senior
managers should facilitate continual process and product improvement.)
ICH Q8, p. 9, Approaches to Pharmaceutical Development
A greater understanding of the product and its manufacturing process can create a basis for more flexible regulatory approaches. The degree of regulatory flexibility is
predicated on the level of relevant scientific knowledge provided in the registration application. It is the knowledge gained and submitted to the authorities, not the
101 volume of data collected, that forms the basis for science- and risk-based submissions and regulatory evaluations.
101
BACKUP SLIDES - GLOBAL

QUESTIONS AND ANSWERS
102
102
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GLOBAL BACKUP 1
A pharmaceutical product is authorized via the Centralised Procedure and administered through the
European Medicines Agency. This authorization is valid in:
1 The EU only
2 The EU, Norway and Iceland
3 Norway, Switzerland, Iceland, the EU, Australia and New Zealand
4 The EU, Canada, Australia and New Zealand
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103
GLOBAL BACKUP 1
A pharmaceutical product is authorized via the Centralised Procedure and administered through the
European Medicines Agency. This authorization is valid in:
1 The EU only
2 The EU, Norway and Iceland
3 Norway, Switzerland, Iceland, the EU, Australia and New Zealand
4 The EU, Canada, Australia and New Zealand
Canada, Australia and New Zealand have independent authorization systems. The EU, Norway and Iceland are parties to the European
Economic Area (EEA), which is subject to centralized authorizations. Switzerland operates under a bilateral agreement with the EU. The drug
authorization by EU’s Centralised Procedure is recognized but not automatically valid in Switzerland.
104
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GLOBAL BACKUP 2
A Marketing Authorization Holder (MAH) has all of the following legal responsibilities, EXCEPT:
1 Communicating critical changes in the manufacturing and control operations to the Competent Authority
prior to implementation
2 Ensuring a Qualified Person is in charge of pharmacovigilance

3 Ensuring all product documentation, including clinical trial information, is retained and archived for 25
years
4 Renewing the Marketing Authorization prior to its expiration date
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GLOBAL BACKUP 2
A Marketing Authorization Holder (MAH) has all of the following legal responsibilities, EXCEPT:
1 Communicating critical changes in the manufacturing and control operations to the Competent Authority
prior to implementation
2 Ensuring a Qualified Person is in charge of pharmacovigilance

3 Ensuring all product documentation, including clinical trial information, is retained and archived for 25
years
4 Renewing the Marketing Authorization prior to its expiration date
The document retention period is not specified. Only Canada requires that clinical documentation be archived for 25 years. The Guidance for
Records Related to Clinical Trials (GUI-0068) states the retention of all records created during the conduct of a clinical trial is 25 years as per
the Regulations. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index_e.html Container closure systems for packaging human drugs and
106 biologics
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GLOBAL BACKUP 3
The steps to marketing authorization for a new pharmaceutical product are performed in the following
order:
1 Submission to the Competent Authority, dossier evaluation, approval, reimbursement application,
pharmacovigilance
2 Submission to the Competent Authority, dossier evaluation, reimbursement application, pharmacovigilance,
approval
3 Submission to the Competent Authority, dossier evaluation, reimbursement application, approval,
pharmacovigilance
4 Pharmacovigilance, submission to the Competent Authority, dossier evaluation, approval, reimbursement
application
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GLOBAL BACKUP 3
The steps to marketing authorization for a new pharmaceutical product are performed in the following
order:
1 Submission to the Competent Authority, dossier evaluation, approval, reimbursement application,
pharmacovigilance
2 Submission to the Competent Authority, dossier evaluation, reimbursement application, pharmacovigilance,
approval
3 Submission to the Competent Authority, dossier evaluation, reimbursement application, approval,
pharmacovigilance
4 Pharmacovigilance, submission to the Competent Authority, dossier evaluation, approval, reimbursement
application
ICH E2E, Pharmacovigilance Planning, November 2004. While many activities related to reimbursement and pharmacovigilance can be planned
and prepared in advance, neither can be activated until approval. Likewise, the pharmacovigilance planning can be prepared in advance, but
data collection begins only after the drug is on the market (i.e., after approval and sales). 1 is the best answer.
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GLOBAL BACKUP 4
You are part of a product development team for an injectable vaccine that is analogous to an existing
vaccine and the planned distribution is in the EU. As the regulatory representative, the first recommendation
you should make to the development team is:
1 Investigate the studies done for other generic products to demonstrate bioequivalence
2 Develop comparability studies to evaluate the quality, safety and efficacy of the vaccine compared to the
existing vaccine
3 Identify a reference product to use for comparability studies of the vaccine quality, regardless of whether
the product is approved in the EU
4 Work with the clinical department to develop an adequate pharmacokinetic study plan
109
109
GLOBAL BACKUP 4
You are part of a product development team for an injectable vaccine that is analogous to an existing
vaccine and the planned distribution is in the EU. As the regulatory representative, the first recommendation
you should make to the development team is:
1 Investigate the studies done for other generic products to demonstrate bioequivalence
2 Develop comparability studies to evaluate the quality, safety and efficacy of the vaccine compared to the
existing vaccine
3 Identify a reference product to use for comparability studies of the vaccine quality, regardless of whether
the product is approved in the EU
4 Work with the clinical department to develop an adequate pharmacokinetic study plan
Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev 1, October 2014)

Guideline on Clinical Evaluation of New Vaccines (CPMP/EWP/463/97, October 2006)
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GLOBAL BACKUP 5
All of the following new biotechnology products are considered obligatory for the Centralised Procedure
EXCEPT:
1 Gene therapy
2 Vaccines from strains developed utilizing recombinant DNA technology
3 Cell therapy that are the result of any biotech process.
4 Fusion Proteins
111
111
GLOBAL BACKUP 5
All of the following new biotechnology products are considered obligatory for the Centralised Procedure
EXCEPT:
1 Gene therapy
2 Vaccines from strains developed utilizing recombinant DNA technology
3 Cell therapy that are the result of any biotech process.
4 Fusion Proteins
The Rules Governing Medicinal Products in the European Union, Volume 2A, Chapter 4, “Centralised Procedure” (April 2006)
Question Feedback
Fusion proteins are not specified/listed as products obligatory for Centralised Procedure.
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GLOBAL BACKUP 6
The US Food and Drug Administration (FDA) generally is considered as a reference agency in drug
regulation and enforcement. For which of the following submission types must FDA conduct a Preapproval
Inspection (PAI) on GMP?
1 All PAI’s are at the discretion of FDA
2 New Drug Application (NDA) with a new manufacturer
3 New Biologics License Application (BLA)
4 New Biologics License Application (BLA) from a foreign manufacturer
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113
GLOBAL BACKUP 6
The US Food and Drug Administration (FDA) generally is considered as a reference agency in drug
regulation and enforcement. For which of the following submission types must FDA conduct a Preapproval
Inspection (PAI) on GMP?
1 All PAI’s are at the discretion of FDA
2 New Drug Application (NDA) with a new manufacturer
3 New Biologics License Application (BLA)
4 New Biologics License Application (BLA) from a foreign manufacturer
FDA Compliance Program (PROGRAM 7346.832). No current regulations require FDA to conduct a GMP audit. A PAI is at FDA’s discretion as
specified in the agency’s Compliance Program Guidance Manual (CPGM) 7346.832, Part II, Section 2.1 “Scope.” This is true even for high-risk
products. For example, FDA CBER’s SOPP 8410 on “Determining when pre-license/preapproval inspections are necessary,” states, while it has
been CBER’s policy to conduct PAIs for all new BLAs and significant manufacturing changes, the inspection still may be waived if justified.
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GLOBAL BACKUP 7
A request to meet with FDA on a previously approved biological product should include all of the following
EXCEPT:
1 A proposed agenda
2 The product’s BLA submission application number
3 A list of specific questions, grouped by discipline
4 The preferred location for the meeting
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GLOBAL BACKUP 7
A request to meet with FDA on a previously approved biological product should include all of the following
EXCEPT:
1 A proposed agenda
2 The product’s BLA submission application number
3 A list of specific questions, grouped by discipline
4 The preferred location for the meeting
Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products (Rev 1 May 2009)
Meetings requested with FDA are at FDA facilities. Answers 1, 2 and 3 are expected to be in a meeting request.
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GLOBAL BACKUP 8
Your company plans to seek approval for a medicinal product containing an active substance also found in
a reference medicinal product authorized for more than 10 years. Approval now will be sought for an
additional indication. The most appropriate application format is:
1 Generic drug application
2 Hybrid drug application
3 Variation application
4 Orphan drug application
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117
GLOBAL BACKUP 8
Your company plans to seek approval for a medicinal product containing an active substance also found in
a reference medicinal product authorized for more than 10 years. Approval now will be sought for an
additional indication. The most appropriate application format is:
1 Generic drug application
2 Hybrid drug application
3 Variation application
4 Orphan drug application
Directive 2001/83/EC, as amended, Art. 10(1)
A generic applicant will not be required to provide the results of preclinical tests and clinical trials and may cross-reference the originator’s dossier if the medicinal product is a generic of a reference
medicinal product that is or has been authorized under a full/self-standing application procedure in the community for at least eight years. Directive 2001/83/EC, as amended, Art. 10(1). Hybrid
applications differ from generic applications in that the results of appropriate preclinical tests and clinical trials will be necessary for the following three circumstances:
(1) The strict definition of a “generic medicinal product” is not met;
(2) Bioavailability studies cannot be used to demonstrate bioequivalence; and
(3) There are changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration of the generic product compared to the reference
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GLOBAL BACKUP 9
You are the regulatory representative for a large pharmaceutical company, which received a Marketing Authorisation for an
innovative pharmaceutical product in Europe five years ago. This product, though approved, was not placed on the market.
The five-year point is approaching and you are asked to compile the renewal dossier. Which of the following best describes
your actions?
1 Review all clinical literature and experience associated with the product so you can re-evaluate the benefit-risk balance
for the product and submit it for assessment to the appropriate Competent Authority.
2 Provide the appropriate Competent Authority with a consolidated version of the file’s quality, safety and efficacy
information and compile a benefit-risk evaluation together with a review of all variations.
3 Explain to your team this Marketing Authorisation cannot be renewed as it is no longer considered valid.
4 Explain to your team a submission does not need to be compiled as the pharmaceutical product has been approved for
five years.
119
119
GLOBAL BACKUP 9
You are the regulatory representative for a large pharmaceutical company, which received a Marketing Authorisation for an
innovative pharmaceutical product in Europe five years ago. This product, though approved, was not placed on the market.
The five-year point is approaching and you are asked to compile the renewal dossier. Which of the following best describes
your actions?
1 Review all clinical literature and experience associated with the product so you can re-evaluate the benefit-risk balance
for the product and submit it for assessment to the appropriate Competent Authority.
2 Provide the appropriate Competent Authority with a consolidated version of the file’s quality, safety and efficacy
information and compile a benefit-risk evaluation together with a review of all variations.
3 Explain to your team this Marketing Authorisation cannot be renewed as it is no longer considered valid.
4 Explain to your team a submission does not need to be compiled as the pharmaceutical product has been approved for
five years.
Directive 2001/83/EC. Any Marketing Authorisation not followed by placing the authorized product on the market within three years in the
authorizing Member State shall cease to be valid. Answer 2 would be correct if you were renewing an authorization that had been placed on
the market. There are exceptions to this, but it would need to be discussed on a case-by-case basis
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120
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GLOBAL BACKUP 10
Company A is going to change its packaging material for a sterile injection solution. From a U.S. regulatory
perspective, which of the following is NOT required to get change approved?
1 Submission of a major change request for approval
2 Safety, compatibility and stability evaluation by R&D
3 Inclusion of the change information in the Annual Report
4 Sterility testing by R&D
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121
GLOBAL BACKUP 10
Company A is going to change its packaging material for a sterile injection solution. From a U.S. regulatory
perspective, which of the following is NOT required to get change approved?
1 Submission of a major change request for approval
2 Safety, compatibility and stability evaluation by R&D
3 Inclusion of the change information in the Annual Report
4 Sterility testing by R&D
FDA, Guidance for Industry—Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol
for Sterile Products (February 2008). FDA, Guidance for Industry—Changes to an Approved NDA or ANDA (April 2004), p.20 IX Container
Closure system, B Major changes, 4 For sterile changes. FDA, Guidance for Industry—Container Closure Systems for Packaging Human Drugs
and Biologics. (May 1999) p.29 Table 4 Information that typically should be submitted for injectable or ophthalmic drug product. According to
FDA guidance, packaging material change for sterile injection solution is a major change and requires safety, compatibility and stability
evaluation. So answers 1) and 2) are incorrect. Sterility testing is recommended in the first guidance mentioned above, so answer 4) is incorrect.
Since it is a major change, it cannot simply be included in an Annual Report, so answer 3) is correct.
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122
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GLOBAL BACKUP 11
A biologics manufacturer needs to scale-up the manufacturing process in anticipation of a change

approval. Which of the following attributes should be evaluated prior to accepting the manufacturing
change?
1 Analytical testing and biological assays
2 Analytical testing, biological assays, clinical and nonclinical data
3 Analytical testing, biological assays, nonclinical and clinical data, stability
4 It depends on what is being changed and what the effect of the change could be
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123
GLOBAL BACKUP 11
A biologics manufacturer needs to scale-up the manufacturing process in anticipation of a change

approval. Which of the following attributes should be evaluated prior to accepting the manufacturing
change?
1 Analytical testing and biological assays
2 Analytical testing, biological assays, clinical and nonclinical data
3 Analytical testing, biological assays, nonclinical and clinical data, stability
4 It depends on what is being changed and what the effect of the change could be
ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process, November
2004. Not enough information is provided to evaluate the change, therefore answer 4 is correct.
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124
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GLOBAL BACKUP 12
All of the following are goals of PIC/S EXCEPT:

1 Mutual recognition of inspections
2 Publication of aide-memoires for medical device inspections
3 Harmonization of GMP requirements
4 Training of inspectors
125
125
GLOBAL BACKUP 12
All of the following are goals of PIC/S EXCEPT:

1 Mutual recognition of inspections
2 Publication of aide-memoires for medical device inspections
3 Harmonization of GMP requirements
4 Training of inspectors
PIC/S, Pharmaceutical Inspection Co-operation Scheme, PIC/S 1/95 (Rev. 4). The PIC/S does not include medical devices.
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126
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GLOBAL BACKUP 13
A clinical trial sponsor CANNOT transfer to Contract Research Organization (CRO):
1 The responsibility to utilize qualified individuals to verify the data
2 The responsibility for the design of the protocol and Case Report Forms
3 The responsibility for the quality and integrity of the trial data
4 The responsibility for implementing Quality Assurance and Quality Control
127
127
GLOBAL BACKUP 13
A clinical trial sponsor CANNOT transfer to Contract Research Organization (CRO):
1 The responsibility to utilize qualified individuals to verify the data
2 The responsibility for the design of the protocol and Case Report Forms
3 The responsibility for the quality and integrity of the trial data
4 The responsibility for implementing Quality Assurance and Quality Control
ICH E6, Guideline for Good Clinical Practice E6, June 1996. The sponsor holds ultimate responsibility for the trial, even though some activities
are carried out by subcontractors. The sponsor holds ultimate responsibility in terms of quality and integrity.
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128
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GLOBAL BACKUP 14
When reporting an adverse event from a drug, the minimum data elements include all of the following
EXCEPT:
1 A healthcare professional’s statement

2 An identifiable patient
3 An identifiable reporter
4 A suspect product
129
129
GLOBAL BACKUP 14
When reporting an adverse event from a drug, the minimum data elements include all of the following
EXCEPT:
1 A healthcare professional’s statement

2 An identifiable patient
3 An identifiable reporter
4 A suspect product
ICH E2D, Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting, November 2003, p. 5. A healthcare
professional’s statement about the adverse event is not necessary for the reporting requirements. It can be any identifiable reporter. 4.2
Minimum Criteria for Reporting “...for the purpose of regulatory reporting, the minimum data elements for an ADR case are: an identifiable
reporter, an identifiable patient, an adverse reaction, and a suspect product…”
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GLOBAL BACKUP 15
The status of the pharmaceutical product and of the applicant for the certificate in the exporting country is
established in the:
1 Good Clinical Practices certificate
2 Good Manufacturing Practices certificate
3 Certificate of Pharmaceutical Product
4 Certificate of Product approval
131
131
GLOBAL BACKUP 15
The status of the pharmaceutical product and of the applicant for the certificate in the exporting country is
established in the:
1 Good Clinical Practices certificate
2 Good Manufacturing Practices certificate
3 Certificate of Pharmaceutical Product
4 Certificate of Product approval
This certificate (CPP), in the format recommended by WHO, establishes the status of the pharmaceutical product and of the
applicant for the certificate in the exporting country.
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132
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GLOBAL BACKUP 16
Which of the following groups is not an invited ICH observer?
1 Health Canada
2 European Free Trade Association (EFTA)
3 International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
4 World Health Organization (WHO)
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133
GLOBAL BACKUP 16
Which of the following groups is not an invited ICH observer?
1 Health Canada
2 European Free Trade Association (EFTA)
3 International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
4 World Health Organization (WHO)
ICH observers include: the European Free Trade Association (EFTA), currently represented by Swissmedic (Swiss Agency for Therapeutic
Products); Health Canada; and the World Health Organization (WHO). The observers have been associated with ICH since its inception to act
as a link with non-ICH countries and regions. IFPMA serves as an “umbrella” organization for the pharmaceutical industry. IFPMA provides
technical documentation to the ICH Secretariat, responsible for coordinating ICH meetings, and liaises with ICH speakers.
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134
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GLOBAL BACKUP 17
You have been asked to develop a pharmacovigilance plan for a drug tested in pre-registration clinical
trials. When developing the drug’s safety specification for special populations, which is the LEAST
important?
1 Healthy adults
2 Children
3 The elderly
4 Pregnant women
135
135
GLOBAL BACKUP 17
You have been asked to develop a pharmacovigilance plan for a drug tested in pre-registration clinical
trials. When developing the drug’s safety specification for special populations, which is the LEAST
important?
1 Healthy adults
2 Children
3 The elderly
4 Pregnant women
ICH E2E, Pharmacovigilance Planning, November 2004. The Safety Specification should be a summary of the important identified risks of a
drug, important potential risks, and important missing information. It also should address the populations potentially at risk (where the product is
likely to be used). Populations to be considered should include (but might not be limited to): children; the elderly; pregnant or lactating women;
patients with relevant co-morbidity such as hepatic or renal disorders; patients with disease severity different from that studied in clinical trials;
sub-populations carrying known and relevant genetic polymorphism; and patients of different racial and/or ethnic origins
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136
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GLOBAL BACKUP 18
Which of the following technical documentation materials sections must be provided in a pharmaceutical
product marketing application?
1 Nonclinical, Safety and Efficacy

2 Nonclinical, Clinical and Safety
3 Quality, Clinical and Efficacy
4 Quality, Safety and Efficacy
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137
GLOBAL BACKUP 18
Which of the following technical documentation materials sections must be provided in a pharmaceutical
product marketing application?
1 Nonclinical, Safety and Efficacy

2 Nonclinical, Clinical and Safety
3 Quality, Clinical and Efficacy
4 Quality, Safety and Efficacy
ICH M4, The Common Technical Document, September 2002. For a pharmaceutical product marketing application, all quality,
safety and efficacy information are required to be submitted in a common format (CTD—Common Technical Document).
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GLOBAL BACKUP 19
You learn a regulatory change will be enacted in the next six months that will require additional nonclinical
testing of your company’s product. As the regulatory manager, what should you do FIRST?
1 Obtain a copy of the proposed regulation and analyze the impact

2 Consult with legal counsel to determine what legal actions can be taken
3 Arrange for an immediate meeting with the company’s executive management
4 Contact the testing facility and schedule additional testing of the product
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139
GLOBAL BACKUP 19
You learn a regulatory change will be enacted in the next six months that will require additional nonclinical
testing of your company’s product. As the regulatory manager, what should you do FIRST?
1 Obtain a copy of the proposed regulation and analyze the impact

2 Consult with legal counsel to determine what legal actions can be taken
3 Arrange for an immediate meeting with the company’s executive management
4 Contact the testing facility and schedule additional testing of the product
Before any action plan can be developed, it is important to review the regulatory change thoroughly and determine how it may affect your
product. With full information, it is possible to outline subsequent steps and meet with appropriate officials in the organization.
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GLOBAL BACKUP 20
How can you confirm the number of patients enrolled in a clinical study and reported in a clinical study
report is adequate to support your marketing application?
1 Review the protocol for statistical considerations to meet the stated endpoints with respect to current
guidance.
2 Review the life table analysis requirements and accompanying report
3 Review the number of subjects for similar studies reported in the professional literature
4 Review reports of the number of patients who declined to participate in the study
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141
GLOBAL BACKUP 20
How can you confirm the number of patients enrolled in a clinical study and reported in a clinical study
report is adequate to support your marketing application?
1 Review the protocol for statistical considerations to meet the stated endpoints with respect to current
guidance.
2 Review the life table analysis requirements and accompanying report
3 Review the number of subjects for similar studies reported in the professional literature
4 Review reports of the number of patients who declined to participate in the study
ICH E3, Structure and Content of Clinical Study Report, November 1995 and ICH E8, General Considerations for Clinical Trials,1997. The
protocol and statistical plan would have been discussed and agreed prior to the start of the trial. Confirmation could be accomplished by
checking the number enrolled against the number agreed in the protocol. The planned sample size and its basis, e.g., statistical considerations or
practical limitations, should be provided. The size of a trial is influenced by the disease to be investigated, the objective of the study and the
study endpoints.
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GLOBAL BACKUP 21
Several months ago, you submitted the final clinical study phase protocol for your company’s new product to a major
health authority for review and approval. The health authority issued a letter indicating your product will be approved if
the studies are completed as outlined and the results meet the pre-specified safety and efficacy criteria. The studies were
completed and yielded results that met the specific criteria. During the final marketing application review, you are
notified by the health authority that your product will not be approved based on a recent withdrawal of a similar product
in another country. What course of action would you recommend to your company?
1 Inform the health authority your company would like to request a meeting to discuss the application and review the
findings
2 Inform the health authority you disagree with its decision since the decision is not based on your product or the results of
your studies
3 Inform the health authority it has an obligation to meet its commitment to approve your application based on previous
written communication
4 Inform your legal department and let them handle all subsequent interactions with the health authority
143
143
GLOBAL BACKUP 21
Several months ago, you submitted the final clinical study phase protocol for your company’s new product to a major
health authority for review and approval. The health authority issued a letter indicating your product will be approved if
the studies are completed as outlined and the results meet the pre-specified safety and efficacy criteria. The studies were
completed and yielded results that met the specific criteria. During the final marketing application review, you are notified
by the health authority that your product will not be approved based on a recent withdrawal of a similar product in another
country. What course of action would you recommend to your company?
1 Inform the health authority your company would like to request a meeting to discuss the application and review the findings
2 Inform the health authority you disagree with its decision since the decision is not based on your product or the results of
your studies
3 Inform the health authority it has an obligation to meet its commitment to approve your application based on previous
written communication
4 Inform your legal department and let them handle all subsequent interactions with the health authority
The company should meet with the regulatory authority to discuss the application and compare the new product to the one withdrawn. There may
be differences in the two products that would allow your company’s application to be approved. Or, your company might be able to use
information on the withdrawn product to make its application approvable. The problem that led to the similar product’s withdrawal in another
country may not apply to your product under evaluation.
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GLOBAL BACKUP 22
You are accompanying a regulatory authority inspector during an inspection of your company’s facilities.
While touring the manufacturing facilities, the inspector requests a copy of your internal GMP guidance.
What is your best course of action?
1 Inform the inspector the company's GMP manual is available at the meeting room for his reference
2 Ask the inspector for more details about why it is necessary to review the internal GMP manual
3 Make a copy of company's internal GMP manual and give to the inspector.
4 Notify the inspector's senior management that it is not possible to provide a complete copy of this
document.
145
145
GLOBAL BACKUP 22
You are accompanying a regulatory authority inspector during an inspection of your company’s facilities.
While touring the manufacturing facilities, the inspector requests a copy of your internal GMP guidance.
What is your best course of action?
1 Inform the inspector the company's GMP manual is available at the meeting room for his reference
2 Ask the inspector for more details about why it is necessary to review the internal GMP manual
3 Make a copy of company's internal GMP manual and give to the inspector.
4 Notify the inspector's senior management that it is not possible to provide a complete copy of this
document.
ICH Q9, Quality Risk Management, November 2005
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GLOBAL BACKUP 23
The following are components of routine risk minimization EXCEPT:

1 A safety specification
2 Risk acceptance
3 An evaluation of the need for risk minimization activities
4 A marketing plan
147
147
GLOBAL BACKUP 23
The following are components of routine risk minimization EXCEPT:

1 A safety specification
2 Risk acceptance
3 An evaluation of the need for risk minimization activities
4 A marketing plan
GHTF SG3N15R8:2005 Risk Management Principles and activities within a QMS.

ICH Q9: 2009 Quality Risk management
FDA, Guidance for Industry: Development and Use of Risk Minimization Action Plans, March 2005
ISO 14971Medical devices—Application of Risk Management to Medical Devices
Question Feedback
Marketing plans are not required for risk minimization. Marketing plans are not designed to minimize known or unknown risk and cannot help to achieve risk reduction.
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74

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2/4/2022

Which type of medicinal product must be screened for long-term carcinogenicity?

Which type of medicinal product must be screened for long-term carcinogenicity?

2 The maximum tolerated dose in male and female rats

4 The cost of the study at a non-GLP laboratory

2 The maximum tolerated dose in male and female rats

4 The cost of the study at a non-GLP laboratory

3 Cytogenetic testing and in vivo genotoxicity in a single tissue type

4 Long-term carcinogenicity testing in two species

3 Cytogenetic testing and in vivo genotoxicity in a single tissue type

4 Long-term carcinogenicity testing in two species

1 The laboratory does not have records of its sanitation procedures

1 The laboratory does not have records of its sanitation procedures

A Certificate of Pharmaceutical Product (CPP) does NOT need to include:

A Certificate of Pharmaceutical Product (CPP) does NOT need to include:

1 The Authorized Person

1 One development batch and one confirmatory batch

1 One development batch and one confirmatory batch

A regulatory professional at a pharmaceutical manufacturing facility is training the production staff on

A regulatory professional at a pharmaceutical manufacturing facility is training the production staff on

4 Obtain a signed informed consent from Company ABC

4 Obtain a signed informed consent from Company ABC

Orphan product designation

Orphan product designation

1 Good Laboratory Practices (GLP)

1 Good Laboratory Practices (GLP)

1 Product stability and storage condition studies

1 Product stability and storage condition studies

1 Target receptor and/or epitope distribution

1 Target receptor and/or epitope distribution

What routine documents must a pharmacovigilance plan include?

What routine documents must a pharmacovigilance plan include?

Which of the following statements about biosimilars is NOT correct?

Which of the following statements about biosimilars is NOT correct?

Which of the following is NOT a requirement for an IRB/IEC?

Which of the following is NOT a requirement for an IRB/IEC?

ICH E6, Good Clinical Practice, June 1996

ICH Q5c, Q6B, Q11

1 Validate the equipment and process prior to manufacturing the supplies.

1 Validate the equipment and process prior to manufacturing the supplies.

A regulatory professional is reviewing documents on producing a human recombinant protein with a

A regulatory professional is reviewing documents on producing a human recombinant protein with a

The correct sequence of risk management activities is:

The correct sequence of risk management activities is:

BACKUP SLIDES - GLOBAL

2 The EU, Norway and Iceland

3 Norway, Switzerland, Iceland, the EU, Australia and New Zealand

4 The EU, Canada, Australia and New Zealand

2 The EU, Norway and Iceland

3 Norway, Switzerland, Iceland, the EU, Australia and New Zealand

4 The EU, Canada, Australia and New Zealand

2 Ensuring a Qualified Person is in charge of pharmacovigilance

4 Renewing the Marketing Authorization prior to its expiration date

2 Ensuring a Qualified Person is in charge of pharmacovigilance

4 Renewing the Marketing Authorization prior to its expiration date

Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev 1, October 2014)

A biologics manufacturer needs to scale-up the manufacturing process in anticipation of a change