This document discusses several topics related to pharmacovigilance including ICH-GCP guidelines, E2B safety reporting standards, Safety Data Exchange Agreements (SDEAs), and Post-Marketing Surveillance and Post-Authorization Safety Studies (PASS). It provides an overview of the key principles of ICH-GCP for ensuring ethical and quality clinical trials. It also describes the E2B R2 and R3 formats for electronic safety reporting, the purpose and components of SDEAs for governing safety data exchange, and the goals and design aspects of PASS for monitoring a drug's safety profile post-approval.

1. ICH-GCP guidelines
E2B R2 & R3
Safety Data Exchange Agreements (SDEAs)
Post-Marketing Surveillance andPost-Authorization Safety Studies
(PASS)
By AnamikaChoudhury

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ICH-GCP:
• The ICH-GCP is a harmonized standard
that protects the rights, safety and welfare of
human subjects, minimizes human exposure
to investigational products, improves quality
of data, speeds up marketing of new drugs
and decreases the cost to sponsors and to
the public.

3. PRINCIPLES OF ICH-GCP GUIDELINES:
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There are 13 core principles of ICH-GCP and they are as follows:
1. Clinical trials should be conducted in accordance with ethical principles that have their origin in
the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory
requirement(s).
2. A trial should be initiated and continued only if the anticipated benefits justify the risks.
3. The rights, safety and well-being of the trial subjects are the most important considerations and
should prevail over interest of science and society.
4. The available non-clinical and clinical information on an investigational product should be
adequate to support the proposed clinical trial.

4. PRINCIPLES OF ICH-GCP GUIDELINES:
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5. Clinical trials should be scientifically sound, and described in clear, detailed protocol.
6. A trial should be conducted in compliance with the protocol that has received prior institutional
review board (IRB)/ independent ethics committee (IEC) approval/favourable opinion.
7. The medical care given to, and medical decisions made on behalf of subjects should always be
the responsibility of a qualified physician or HCP.
8. Each individual involved in conducting a trial should be qualified by education, training, and
experience to perform his or her respective task(s).
9. Freely given informed consent should be obtained from every subject prior to clinical trial
participation.
10. All clinical trial information should be recorded, handled, and stored in a way that allows its
accurate reporting, interpretation and verification.

5. PRINCIPLES OF ICH-GCP GUIDELINES:
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11. The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality rules in accordance with the
applicable regulatory requirement(s).
12. Investigational products should be manufactured, handled and stored in
accordance with applicable Good Manufacturing Practice (GMP). They should be
used in accordance with the approved protocol.
13. Systems with procedures that assure the quality of every aspect of the trial
should be implemented.

6. PRINCIPLES OF ICH-GCP GUIDELINES:
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These principles are self-explanatory and, when summarised, simply mean:
All clinical trials should be conducted in accordance with ethical principles, sound
scientific evidence and clear detailed protocols. The benefits of conducting trials
should outweigh the risks. The rights, safety and well-being of trial participants
are of paramount importance and these should be preserved by obtaining
informed consent and maintaining confidentiality. The care must be given by
appropriately qualified personnel with adequate experience. Records should be
easily accessible and retrievable for accurate reporting, verification and
interpretation. Investigational products should be manufactured according to
Good Manufacturing Practice.

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E2B R2 & R3 Reports:
The E2B is a standard format developed by the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) to facilitate the electronic submission of safety
data in PV.
E2B R2, also known as the ICH E2B(R2) standard, was introduced in 2001 as an update to the original
E2B format. The E2B R2 format supported the electronic transmission of adverse drug reaction (ADR)
reports and provided a standardized structure for the content and format of safety data.
E2B R3, or ICH E2B(R3), is the most recent version of the E2B standard, which was implemented in 2016.
It aims to improve the quality, consistency, and efficiency of safety reporting. E2B R3 introduced new data
elements and structures to accommodate emerging safety-related information and evolving regulatory
requirements. It incorporates advancements in technology, such as the use of XML-based data exchange,
to enhance data interoperability and facilitate global harmonization in PV.
Summary: E2B R2 and R3 reports in PV represent standardized formats for the electronic
submission and exchange of safety data. They have played a vital role in enhancing
pharmacovigilance activities, ensuring the timely and accurate reporting of adverse events, and
promoting global harmonization in drug safety assessment and surveillance.

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Safety Data Exchange Agreements (SDEAs)
1.Definitions: An SDEA is a legal agreement between two parties involved in the development,
marketing, or distribution of a medicinal product, such as a pharmaceutical company and a contract
research organization (CRO) or a marketing authorization holder and a distributor.
2.Scope: The agreement clearly defines the scope of safety data exchange, specifying the medicinal
product(s) covered, the geographical areas involved, and the timeframes for reporting.
3.Responsibilities: The SDEA outlines the specific responsibilities of each party in relation to safety
data collection, evaluation, and reporting. It defines the roles of the marketing authorization holder, the
CRO, or any other involved party, including the processes for case identification, data collection,
causality assessment, and submission to regulatory authorities.
4.Communication: The agreement establishes clear lines of communication between the parties
regarding safety data exchange. It specifies the methods and frequency of reporting, channels of
communication, and contact points for safety-related matters.

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Safety Data Exchange Agreements (SDEAs)
5. Timelines: The SDEA includes timelines for the submission of safety data, such as individual case
safety reports (ICSRs), periodic safety update reports (PSURs), or other relevant safety information. It
ensures that the parties adhere to regulatory requirements and reporting deadlines.
6. Confidentiality: The agreement addresses the confidentiality and protection of safety data. It
defines the rules for data access, data sharing, and data security to maintain the privacy and integrity
of patient information.
The SDEA is an essential document that governs the exchange of safety data and promotes
compliance with regulatory requirements in pharmacovigilance. It helps to ensure the timely and
accurate reporting of adverse events

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Post-Marketing Surveillance and Post-Authorization Safety Studies
(PASS)
Definition: PASS stands for Post-Authorization Safety Study, and it is a type of study conducted in the
field of pharmacovigilance (PV). A PASS is carried out after a medicinal product has received
regulatory approval and is on the market. Its primary objective is to gather additional information about
the safety profile of the product in real-world clinical practice.
Purpose: The purpose of conducting a PASS is to further assess the safety of a medicinal product. By
collecting data on the product's safety in routine clinical use, a PASS can help identify and characterize
rare or long-term adverse effects that may not have been captured in the initial clinical development
stages.
Key aspects of a PASS in PV include:
1. Study Design: A PASS should have a well-defined study design that outlines the objectives,
methodology, and data collection procedures. It may involve different study designs, such as
prospective cohort studies, case-control studies, or registry-based studies, depending on the research
question and available data sources.

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Post-Marketing Surveillance and Post-Authorization Safety Studies
(PASS)
2. Data Sources: A PASS utilizes various sources of data, including electronic health records, medical
claims databases, patient registries, and spontaneous adverse event reporting systems. These sources
provide information on patients' medical history, medication usage, and reported adverse events.
3. Study Population: The PASS typically includes a large and diverse population, representative of the
patient population who will be using the medicinal product in real-world clinical practice. This allows for
the evaluation of the product's safety across different patient subgroups and clinical settings.
4. Safety Endpoints: The study identifies specific safety endpoints of interest, such as the occurrence
of adverse events, serious adverse events, or specific safety concerns. These endpoints are carefully
defined and standardized to ensure consistent data collection and analysis.
5. Data Collection and Analysis: Data is collected through various methods, including medical record
review, patient interviews, or electronic data extraction. Robust data management and statistical
analysis methods are applied to evaluate the safety outcomes and assess any potential associations
between the use of the medicinal product and adverse events

12. Thank you