The document outlines the risk management process in pharmacovigilance, emphasizing its role in promoting the safe use of medicines and protecting patient health. It includes activities for identifying risks, assessing safety profiles, and implementing mitigation measures, all integral to the risk management plan required during drug authorization. The document also describes the legal framework and ongoing evaluation needed to minimize risks associated with drug products post-marketing.

1. Welcome
RISK MANAGEMENT PROCESS IN
PHARMACOVIGILANCE
Kalakada Bhavya Sree
M. Pharmacy
CSRPL_STD_IND_HYD_ONL/CLS_172/082023
10/18/2022
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2. INDEX
• Introduction
• Definition
• Aim and Objectives
• Parts of RMP
• Different Steps of Risk Management
• Risk Management Legal Framework
• Risk Management Cycle
• Summary
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3. INTRODUCTION
 Risk management in pharmacovigilance is to promote the safe use of medicines and safeguard
health of patients.
 It is a set of activities performed for identification of risk, risk assessment, and risk
minimization and prevention.
 Risk management has the following stages: identification and characterization of the safety
profile of the medicinal product; planning of pharmacovigilance activities to characterize risks
and identify new risks; planning and implementation of risk minimization and mitigation and
assessment of the effectiveness of these activities; and document post approval obligations that
have been imposed as a condition of the marketing authorization.
 All these activities together constitute the risk management plan, which is required to be
submitted during the authorization of the drug.
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4. DEFINITION
 A set of pharmacovigilance activities and interventions designed to identify, characterize,
prevent or minimize risks relating to medicinal products, including the assessment of the
effectiveness of those interventions.
AIM & OBJECTIVES OF THE RMP
 The overall aim of risk management is to ensure that the benefits of the medicinal product
outweigh the risks by a wide margin for the treatment of a particular indication both at
individual level and for the target population as a whole.
 Identify or characterize safety profile.
 Measures to prevent or minimize risks including assessment of the effectiveness.
 Document post-authorisation obligations.
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5. PARTS OF RMP
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6. DIFFERENT STEPS OF RISK MANAGEMENT
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RISK DETECTION AND
ASSESSMENT
Identify the risks
Preclinical studies
Harms identified in clinical trials & meta-analyses
Formal mortality and morbidity studies
Understand the risk
Rigorous case definition
Case series analysis
Clear description in label
Monitor the risk
Post marketing surveillance
Database analyses
Prospective cohort studies and registries (to study
potentially rare but important risks where risk
identification or product attribution is difficult)
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RISK MINIMISATION AND
COMMUNICATION
Communicate the risk
Advice in label (not enough to communicate
specific risk minimization activities or
change behaviors)
Partnership with regulators
Education of physicians, patients, company
staff
Act to reduce the risk
Limited distribution
Limited prescribing rights
Contra-indicate for certain groups,
indications, routes of
administration
Advice for high risk groups
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8. RISK MANEGEMENT LEGAL FRAMEWORK
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9. RISK MANAGEMENT CYCLE
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10. SUMMARY
 Risk Management represents a growing awareness of the need for continuing evaluation of
risks related to drug products and the implementation of plans to minimize those risks after
marketing.
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11. Thank You!
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