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Pharmacovigilance Useful Slides PDF
Pharmacovigilance Useful Slides PDF
Pharmacovigilance Useful Slides PDF
Pharmacovigilance
• The science and activities relating to the
detection, assessment, understanding and
prevention of adverse effects or any other
drug-related problem
• Adverse Event
License Partner
• Clinical Trial
Any investigation in human subjects intended to discover or verify the
clinical, pharmacological and/or other pharmacodynamic effects of one or
more investigational medicinal product(s), and/or to identify any adverse
reactions to one or more investigational medicinal product(s) and/or to
study absorption, distribution, metabolism and excretion of one or more
investigational medicinal product(s) with the object of ascertaining its
(their) safety and/or efficacy
• Interventional Trial
An interventional clinical trial is any research study that prospectively
assigns people to one or more health-related interventions (e.g.,
preventive care, drugs, surgical procedures, behavioral treatments, etc.) to
evaluate their effects on health-related outcomes. (CIOMS VII) .
• Non-Interventional Study
A study where the medicinal product(s) is (are) prescribed in the usual
manner in accordance with the terms of the marketing authorization. The
assignment of the patient to a particular therapeutic strategy in not
decided in advance by a trial protocol but falls within current practice and
the prescription of the medicine is clearly separated from the decision to
include the patient in the study. No additional diagnostic or monitoring
procedures shall be applied to the patients and epidemiological methods
shall be used for the analysis of collected data.
• Literature
Denotes published articles/abstracts in scientific and
medical journals and unpublished manuscripts involving
adverse events which appear as case reports or from
formal clinical studies in which there is an identifiable
patient.
• Named-Patient Program
The use of a medicinal product to treat patients for whom
conventional therapies have failed, or for whom no other
drug exists. This procedure is used with very sick individuals
who have no other treatment options available and often,
case-by-case approval must be obtained from the
regulatory authority
• Registry
A registry is a list of patients presenting with the same characteristic(s). This
characteristic can be a disease (disease registry) or a specific exposure (drug
registry). Both types of registries, which only differ by the type of patient data of
interest, can collect a battery of information using standardized questionnaires in a
prospective fashion.
Note: Reporting requirements for case reports from a registry differ depending on
the design of the registry (e.g. registry is considered as interventional, non-
interventional, or spontaneous), as well as local country reporting requirements
Regulatory authority
Any competent regulatory authority or other governmental body having the power
to regulate and responsible for granting any Regulatory Approval.
Types of reports
• Solicited Reports
These are reports that are derived from organized data collection systems,
which include clinical trials, post-authorization studies, studies in claims
data, registries, post-approval named patient use programs, other patient
support and disease management programs, surveys of patients or
healthcare providers, or information gathering on efficacy or patient
compliance. These are reports that are derived during planned contacts
and active solicitation of information from patients, healthcare
professionals, or organizations.
Spontaneous
An unsolicited communication to a company, regulatory authority, or
other organization that describes an adverse reaction in a patient given
one or more medicinal products and which does not derive from a study
or any organized data collection scheme
• Blinding
A procedure in which one or more parties to the trial
are kept unaware of the treatment assignment(s).
Single-blinding usually refers to the subject(s) being
unaware, and double-blinding usually refers to the
subject(s), investigator(s), monitor, and, in some cases,
data analyst(s) being unaware of the treatment
assignment(s).
In relation to an investigational medicinal product,
blinding shall mean the deliberate disguising of the
identity of the product. Unblinding shall mean the
disclosure of the identity of the blinded products.
• National Competent Authority (NCA)
An authority within the EEA (European Economic Area)
including the EMEA and the European Commission
responsible for the clinical trial and granting of marketing
authorizations for medicinal products and the
supervision of marketing of such products in accordance
with the relevant laws and regulations established under
Community law.
• Marketing Authorization Holder (MAH)
An organization holding a valid marketing authorization
for a medicinal product independent of the authorization
procedure of this medicinal product.
• Causality
Determination of whether there is a reasonable
possibility that the product is etiologically related to
the adverse experience.
• CIOMS 1 form
This is a form with standardized elements and
formatting for reporting adverse events. It was agreed
by the Council for International Organizations of
Medical Sciences (CIOMS) in collaboration with WHO.
Prior to finalization, the form was pretested in a two-
year pilot project involving seven manufacturers and
some 40 affiliates.
• Coding
The process of selecting terms and codes from
a standardized dictionary for a given verbatim
term (i.e. suspect drug, concomitant drug,
adverse events. Indication, medical history,
laboratory tests, etc.).
• Expected/Listed vs. Unexpected/Unlisted
• Expected
An adverse reaction, the nature, or severity of which is consistent with the
applicable product information (i.e. local labeling/prescribing information).
• Listed
Listed or listedness refers to the fact that an adverse reaction is “listed” in the
Company Core Safety Information (CCSI) of the concerned product.
The CCSI, which is embedded in the Company Core Data Sheet (CCDS) forms the
basis for determining whether an adverse reaction is already listed or is still
unlisted (listed and unlisted are terms that are introduced to distinguish them
from the usual terminology of expectedness, which is used in association with the
authorized reference safety information (e.g. SPC, US PI).
Listedness is used to classify adverse events in the PSUR.
• Unexpected
An ADR whose nature, severity, specificity, or outcome is not consistent
with the term or description used in the local/regional product labeling or
other applicable product information (e.g. Investigator’s Brochure for an
unapproved investigational medicinal product, Package Insert or Summary
of Product Characteristics) should be considered unexpected. (ICH E2A,
E2D )
Unlisted
An adverse reaction which is not specifically included as a suspected
adverse effect in the company care safety information (CCSI). This includes
an adverse reaction whose nature, severity, specificity or outcome is not
consistent with the information in the CCSI. It also includes class-related
reactions which are mentioned in the CCSI but which are not specifically
described as occurring with this product. (Volume 9a)
Expedited Report and Aggregate
Report
• Expedited Report
An individual case safety report (ICSR) that is required
to be submitted to a regulatory authority in either a 7
or 15 calendar-day time frame, or to other recipients in
such a time frame so as to enable them to fulfill 7 or 15
calendar-day reporting timeframes.
Aggregate Report
A regulatory required periodic or ad hoc report that
provides a succinct narrative summary and analysis of
the risk-benefit balance for an individual product or a
safety issue.
What is follow up report?
• Concomitant medication
Concomitant medication is any medication (except medication considered
as suspect) taken around the same time that the adverse event occurred.
• Interacting drug
All interacting drugs are considered to be suspect drugs. Thus, there must
be at least two suspect drugs for drug interaction and both have to be
considered as suspect drugs.
• Nullification of an ICSR:
• Suppression of a case: