Pharmacovigilance

PSMF
Advanced Trainer from AUT
Founder of the initiative
‫كبسولة وعي‬
Rules
 Agenda:
• What is Pharmacovigilance system master
file (PSMF).
• PSMF template.
• Summary of master file.
• Break
• Work-Shop.
What is Pharmacovigilance?
“The science and activities relating to the
Detection, assessment, understanding and
prevention of adverse drug effects or any other
drug- related problems”

Detection Assessment Understanding Prevention

What is Pharmacovigilance system master file
(PSMF).
PSMF template
cover page
Table of content.
List of abbreviations.
List of tables.
1.PSMF section on " Qualified person for pharmacovigilance (QPPV) “
2. PSMF section on " Organizational structure of the Marketing Authorization Holder"
3. PSMF section on " The Sources of Safety Data“
4. PSMF section on "Computerized system and Databases"
5. PSMF section on "Pharmacovigilance Processes"
PSMF template
6. PSMF section on "Pharmacovigilance System Performance“
7. PSMF section on "Quality System“
8. PSMF "Annexes"
 cover page
Pharmacovigilance System Master File
Version “…"
Marketing Authorization Holder (MAH):…………………
PSMF location: ………………
Reference No: ………….
Version Number: ………….
Date of preparation:…………..
Date of sign. Off:……………..
Date of submission:…………….
Last Update: Ver.“…" issued on “……….“
Date of preparation of first edition: Ver.“1" issued on “………….“
MAH's Other PV System Master Files:……………..
Other concerned MAH's:………………
Company profile number:…………..
Commercial registry number:……..
Signature:
Name and contact data of the QPPV
Name of QPPV:
Telephone no:
e-mail address:

Statement of confidentiality:………….
Table of content.

List of abbreviations.

List of tables.
 1.PSMF section on " Qualified person for
pharmacovigilance (QPPV) "
1.1. Description of all QPPV responsibilities:

1.2. Summary of QPPV' S C.V:

1.3. QPPV contact details:

1.4. Back-up arrangements:

Summary of Back-up QPPV' S C.V:
1.5. Training checklist for both QPPV and Back-up:

Checklist of the QPPV required practical experience and training.

 Practical experience* Training

Pharmacovigilance methods. √ √

MedDRA coding. √ √

ICSRs processing activities √ √

Evidence based-medicine, How to conduct literature search. √ √

Causality assessment. √ √

Case Narrative Writing for Reporting Adverse Events. √ √

Pharmacovigilance quality management √ √

Pharmaco-epidemiology. √ √

Biostatistics. √ √

Signal detection. √ √

Medical Aspects of Adverse drug reactions. √ √

Risk Benefit assessment in Pharmacovigilanc. √ √

National pharmacovigilance regulations. √ √

How to prepare PSUR. √ √

Pharmacovigilance Planning and Risk Management Plans. √ √

How to prepare PSMF. √ √

Risk communication, DHPC. √ √

Checklist of the Back-up required practical experience and training.
Practical experience* Training

Pharmacovigilance methods. √ √
MedDRA coding. √ √
ICSRs processing activities √ √

Evidence based-medicine, How to conduct literature search. √ √

Causality assessment. √ √

Case Narrative Writing for Reporting Adverse Events. √ √

Pharmacovigilance quality management √ √

Pharmaco-epidemiology. × √
Biostatistics. × √
Signal detection. √ √

Medical Aspects of Adverse drug reactions. √ √

Risk Benefit assessment in Pharmacovigilance. √ √

National pharmacovigilance regulations. √ √

How to prepare PSUR. √ √

Pharmacovigilance Planning and Risk Management Plans. √ √

How to prepare PSMF. × √

Risk communication, DHPC. √ √
1.6. For multinational MAH/ applicant; information relating to
the LSRs on the national level:

1.7. A list of tasks that have been delegated by QPPV:

 Annex A "The QPPV"
1-The QPPV'S C.V.
2-C.V of Back-up
3-Auto-reply e-mail (A screen shot of autoreply e-mail)
4-Contact details of QPPV
5-Contact details of deputy QPPV
6-Nomination letter of QPPV
7-Job Description of QPPV
8-Job Description of Back-up of QPPV
9-Delegation letter by QPPV to Back-up
10-QPPV'S Training courses
11-Back-up QPPV'S Training courses
 2. PSMF section on " Organizational structure of the
Marketing Authorization Holder"
2.1. Description of the organizational structure of MAH relevant to the PV
system

Pharmacovigilance department has relationship with other company departments that may be
involved in PV activities including:
a. Regulatory sector: responsible for update of PL (patient leaflet), packaging, labels and inform
PV department approval dates of new Reg and Re-Reg to submit pharmacovigilance file
according to the regulation of registration of ministry of health and population (decision of 425
in 2015), providing PV department with information about medicinal products with reference
to any authority request concerning the safety of medicinal products and keep PV department
up to date with information about any new application and authorization.
a. Marketing and sales sector: provide PV department with I.M.S data, post marketing studies if
any (eg: Serving), responsible for follow-up reports of ICSRs and responsible for dissemination
of any required PV documents (DDLs, Educational Materials...etc) and any post marketing
studies. Provide QPPV with co-marketing and distributer inside and outside Egypt to make
SDEA with them.
b. Scientific office: trained medical representative responsible for collecting ICSRs from HCP
during visits ensure validity of reports.
c. Export sector: provide PV department with World Wide Authorization Status.
d. IT sector: maintenance of computer system (the software and hardware of the
pharmacovigilance system), connect PV department with server to back up files to be saved.
a. Legal counselor: provide PV department with any contract with other parties (co-marketing, co-
manufacturing, co-distributing or service provider).
b. Finance sector: buy all the pharmacovigilance needs and pay all their dues.
c. Quality Assurance sector: responsible for preparing and update of SOPs, internal audit to quality
system of PV department, audit contractual partners (e.g. CROs), Inform PV team upon receipt of
quality complains& customer complaints associated with an AE, provide information on significant
manufacturing changes having potential impact on product safety, assist PV department in case of
PV inspection from regulatory authority/ies (e.g. EPVC) and assist in preparing the annual training
program.
d. HR sector: arrange the training session and any material related to the training. Support PV in hiring
process of PV team members and preparation of job description of PV team members.
e. Medical affairs department.
 Organizational structure of PV department activities
Signal detection&
Maintenance of PSMF PV department analysis

RMP management
Evaluation of ICSRs
QPPV and Back-up PBRER&ACO production
Assessment of &submission
person
regulatory
authority reports
Medical assessment
Literature searches of ICSRs

Pre-post
Training of company authorization Electronic reporting of
employees& provision of study ICSRs (in form of excel
training materials management sheet)
2.2. Delegated activities
 Annex B "The organizational structure of the MAH":

1-Commercial registry.

2-Organizational structure of the Marketing Authorization Holder (MAH)

relevant to the pharmacovigilance system.

3-The list of contracts and agreements (table).

Partner Nature of Concerned Territory MAH in the SDEA status
(Third party) agreement product territory (Y/N)

------ Manufacturing ------- Egypt ----- Yes

Distribution Egypt

Co-Marketing Egypt

Export Saudi Arabia

4-Copy scanned of contracts (manufacturer, co-marketing, distributers,
export,..)
 3. PSMF section on " The Sources of Safety Data"

3.1. Spontaneous reporting

3.2. Main stages, timeframes, and departments &/or third parties involved in
the process for ICSRs
3.3. List of sources include data a rising from study sources
 Diff. sources of To EPVC
cases Yes within 15
days

HCP
PV
Literature department
Serious
Patient/Consumer (QPPV& his
ness
Backup
Internet/media person
Marketing sector

To EPVC
No within 90
days

Spontaneous reporting and process of ICSRs

Annex C "Sources of safety data"
a) Flow diagram for ICSRs handling process starting from Collection of
ICSRs to report to EPVC
b) Outflow (Signal detection, reporting to EPVC and reflected data in
PBRER)
c) List associated with description of sources of safety data
d) Key words used for weekly screening covered all products
e) Screen shot of weekly screening.
f) Table of contractual partners :( manufacture, distribution and export)
Partner Product Territory Contact details of
responsible safety
personnel (in the 3rd
party)

Egypt Name: ….

Mobile no:

E-mail:
•A list of clinical studies/ Patient Support Programs/ non-interventional studies, Bio-
equivalence studies that are ongoing or completed within the last two-years period:

Active Main Status Countries Products Study no

Ingredient Objective involved
(title)
--------- ---------- --------- --------- -------- ---------
 4. PSMF section on "Computerized system and Databases"

4.1. Description of database (complied with international agreed standers

ICH-E2B)
Tracking excel sheets describing PV activities for:
- ICSRs evaluation and reporting.
- PBRER submission to EPVC according to EURD list.
- RMPs submission training records to different parts of the company.
- EPVC meeting.

4.2. Description of computer system Hardware

 Annex D "Computerized systems and Databases"

- MedDRA subscription license in accordance with MSSO license legalization rules

-All Pharmacovigilance activities are saved in excel sheets.

 5. PSMF section on "Pharmacovigilance Processes"

5.1. Description of the processes and procedural documentation available

5.2. Description of the main Pharmacovigilance processes

Eg:
5.2.1. Archiving to Pharmacovigilance documents
5.2.2. Auditing to Pharmacovigilance system (This procedural document (PVS14) describe
audit process to pharmacovigilance system…..)
5.3. list of the processes for compliance management
 Annex E" Pharmacovigilance Process and written procedures"

1-A list of standard operating procedures (SOPs):

Objective Code number Version SOP title Effective date

Designed for PVS02 1/0 QPPV 01/01/2022

identification of QPPV Responsibilities
responsibilities within
the
pharmacovigilance
team to assure
working and
maintenance of PV
system inside the
company.
SOPs are attached (copy scan).

2-A table of Cross matching between each PV process & SOP:

Corresponding
Process Interfaces
Procedure
 6. PSMF section on "Pharmacovigilance System
Performance"
6.1. Description of the monitoring methods.
6.2. Targets for the performance of the pharmacovigilance system.
Pharmacovigilance system must achieve its targets as spontaneous tasks not less than 90%, periodicity of known
time not less than 90% and responding to authority 100% to ensure that the system is performed.

6.3. List of performance indicators (KPIs):

List of KPIs is provided in annex F and alongside the results of (actual) performance measurements. (In annual
basis)
 Annex F " Pharmacovigilance System Performance"
a)Performance indicators (KPIs).

b) Deviations from Regulatory Compliance.

Case ID Case First Submitted on Number of

seriousness Awareness days
date
----------------- ----------------- ----------------- ---------------- ---------------

c) Table of submitted PSURs.

 7. PSMF section on "Quality System"

The overall quality objectives of the Quality Management system are:

 To comply with the legal requirements for PV tasks and responsibilities.

 To prevent harm from adverse reactions arising from the use of authorized medicinal
products within or outside the terms of MA or from occupational exposure.
 To promote the safe and effective use of medicinal products.
 To contribute to the protection of patients' and public health.
 Define prepare document
Plan
Evaluate

correct
Do
Inputs Act
Outputs

Measure Execute

compare Check Record

Requirements Compliance

Quality Management system

Quality is built in system of pharmacovigilance.

7.1. Document and record control.

7.2. Procedural documents.

7.3. Training.

7.4. Auditing.
 Annex G " Quality System"

Audit

Date of Date of Audit Scope Who/ Completion Significant

Audit Report report Where status findings
reference (site/service (closed/ (Yes(open)/
number provider/act ongoing) Yes (but
ivity) already
solved)/
No
Training
(training materials, annual training plan, training records,..)

Organogram indicating the no. of employees in each department

 Annex H "Products"

1-List of products

Total no. of products

…..

No. of registered products

……

No. of marketed products

……

No. of products under-registration

…..
2-The list of safety monitoring requirements, including safety issues and
requirements for each product:
Active ingredient Fulfilled
Product Safety Issue Requirements (Y/N)

Ciprofloxacin Ciprofloxacin Risk of Aortic Distribution of Yes

aneurysm and DDL (Dear
dissection, Doctor Letters)
Hypoglycemia,
Mental health
side effects and
Musculoskeletal
side effects
 Annex I "Document and Record Control"

Logbook:

Logbook for updates of master file

Version Number Section/ Annex Changes in details Effective date

 Summary of master file
•Cover page.
•Table of content.
•List of abbreviation.
•1-Proof that the applicant has at his disposal a qualified person responsible for
Pharmacovigilance.
•2. The country in which the Qualified person resides and carries out his/her tasks.
•3. The contact details of Qualified person (QPPV).
•4. A statement signed by the applicant to the effect that the applicant has the necessary
means to fulfill on the national level the Pharmacovigilance tasks and responsibilities listed
in the GVP modules and to collect and notify all suspected adverse events should be
provided.
•5. A reference to location where the Pharmacovigilance system master file for medicinal
product is kept.
•Annexes.
Shaimaa El.Nadi Hassan El.Nadi
Mobile No: 01061034133
Email:
elnadis@yahoo.com
shaimaaelnadi@gmail.com