Safety reports rmp risk management plan pharmacovigilance

Safety Reports:RMP: Risk Management Plan

Index

1. What is a Risk Management Plan?

2. Dates of implementation

3. Objective of the RMP

4. Definitions

5. When is a RMP necessary?

6. Structure

SAFETY REPORT: RMP

1. WHAT IS A RISK MANAGEMENT PLAN (RMP)?

A Risk Management Plan is a document based on:

1. Safety profile of the medicine.

2. Plan of all pharmacovigilance activities.

3. Planning and implementation of different measures in order to minimize risk; and evaluation of effectiveness of those measures.

If you want to get more information check out the following link:

GVP Module V: Risk Management Plan

2. DATES OF IMPLEMENTATION

3. OBJECTIVE OF THE RMP

• Early identification of any risk taking into consideration all the existing information

• Identification of areas where it is necessary to perform an in depth evaluation

• Project new studies to characterize and identify scientific-based risks.

• Pharmacovigilance starts before marketing authorization and it continues during all the life-cycle.

4. DEFINITIONS

• Risk Management System:Set of activities to identify, characterize, prevent or minimizeany risk related to medicinal products, including evaluation ofeffectiveness of these measures.

• Risk Management Plan:Detailed description of the Risk Management System.It includes all the existing and missing information about thesafety profile of the medicine; certainty level of theeffectiveness shown in clinical trials, measures to prevent anyrisk associated to the medicine including evaluation ofeffectiveness of these measures.

4. DEFINITIONS (2)

• What is an important identified risk?

An adverse event for which there is enough evidence to associate the riskwith the medicine:

• An adverse event that occurs in pre-clinical and is confirmed by clinicaldata.

• An adverse event identified in clinical trials or epidemiological studieswhen the magnitude of the difference with the comparator groupsuggests that there is a causality relationship.

• An adverse event suggested by a large amount of well-documentedspontaneous reactions with causality strongly supported by:

❖ Temporal relationship.

❖ Biological plausability.

4. DEFINITIONS (3)

• What is an important potential risk?

An adverse event for which there is a suspicion of association with themedicine, but causality is not confirmed:

• Pre-clinical toxicological findings that have not been confirmed byclinical data.

• An adverse event observed in clinical trials or epidemiological studieswhen the magnitude of the difference with the comparator group is notenough to establish a causality relationship.

• A signal obtained by spontaneous notification.

• A class efect.

4. DEFINITIONS (4)

• What is missing information?

Unknown information about the safety of medicines representing a limit insafety data

Populations not studied in clinical trials: pregnant women, patients withhepatic/renal failure, paediatrics, etc.

5. WHEN IS A RMP NECESSARY?

New Marketing Authorization, independently of its legal type of application.

Traditional herbal products and homeopathic products registered under asimplified procedure are exented to develop a RMP.

When it is required by a Regulatory Agency.

6. STRUCTURE OF A RMP

I. Part I: General Overview of the medicine

II. Part II: Safety Specification

III. Part III: Pharmacovigilance Plan

IV. Part IV: Plan for post-authorisation efficacy studies

V. Part V: Risk Minimisation Measures

VI. Part VI: Summary of RMP

VII. Part VII: Annex

a. General Overview of the medicine

b. Safety Concerns

Summary of the safety profile, including

❖ Important Identified Risks

❖ Important Potential Risks

❖ Missing information

❖ Potential populations at risk

❖ Safety gaps that must be under follow-up

c. Pharmacovigilance Plan

The objective of a MAH is to early identify and/or characterize any potentialrisk.

❖ Identify any new safety concern

❖ Better understanding of known concerns

❖ Investigate if those risks are likely to be real.

❖ To expose how MAH plans to obtain better information

All these activities can be:

Routine PV Activities Additional PV Activities

d. Post-marketing Research Plan

Post-authorisation efficacy studies refer to current indications and not to research aimed at extending the indication.

Summary figures of planned studies, together with the agenda and protocolsof all drafts, should be included in Annex 8 of the RMP.

e. Risk Minimization Measures

According to the safety concerns, the MAH must assess the need for riskminimization activities for any risk included in the RMP.

These should be considered on a case by case basis, and they will depend onrisk severity, indication, targeted population, etc.

A single risk can have more than one risk minimization measure.

Each risk minimization measure must be reviewed on a regular basis and itseffectiveness must be assessed (GVP module XVI).

f. Summary of the RMP

The RMP Part VI:

• is made publicly available, including key factors of the RMP and emphasizing on risk minimization activities.

• should be written in a non specialized language (lay language)

• describes all risks taking into account the benefits associated to theuse of that medicine

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