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Safety Reports:
RMP: Risk Management Plan

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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

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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

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2. DATES OF IMPLEMENTATION

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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.

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4. DEFINITIONS
• Risk Management System:
Set of activities to identify, characterize, prevent or minimize
any risk related to medicinal products, including evaluation of
effectiveness of these measures.
• Risk Management Plan:
Detailed description of the Risk Management System.
It includes all the existing and missing information about the
safety profile of the medicine; certainty level of the
effectiveness shown in clinical trials, measures to prevent any
risk associated to the medicine including evaluation of
effectiveness of these measures.

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4. DEFINITIONS (2)
• What is an important identified risk?
An adverse event for which there is enough evidence to associate the risk
with the medicine:
• An adverse event that occurs in pre-clinical and is confirmed by clinical
data.
• An adverse event identified in clinical trials or epidemiological studies
when the magnitude of the difference with the comparator group
suggests that there is a causality relationship.
• An adverse event suggested by a large amount of well-documented
spontaneous reactions with causality strongly supported by:
❖ Temporal relationship.
❖ Biological plausability.

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4. DEFINITIONS (3)
• What is an important potential risk?
An adverse event for which there is a suspicion of association with the
medicine, but causality is not confirmed:
• Pre-clinical toxicological findings that have not been confirmed by
clinical data.
• An adverse event observed in clinical trials or epidemiological studies
when the magnitude of the difference with the comparator group is not
enough to establish a causality relationship.
• A signal obtained by spontaneous notification.
• A class efect.

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4. DEFINITIONS (4)
• What is missing information?
Unknown information about the safety of medicines representing a limit in
safety data
Populations not studied in clinical trials: pregnant women, patients with
hepatic/renal failure, paediatrics, etc.

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5. WHEN IS A RMP NECESSARY?
New Marketing Authorization, independently of its legal type of application.
Traditional herbal products and homeopathic products registered under a
simplified procedure are exented to develop a RMP.
When it is required by a Regulatory Agency.

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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

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a. General Overview of the medicine

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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

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c. Pharmacovigilance Plan
The objective of a MAH is to early identify and/or characterize any potential
risk.
❖ 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

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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 protocols
of all drafts, should be included in Annex 8 of the RMP.

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e. Risk Minimization Measures
According to the safety concerns, the MAH must assess the need for risk
minimization activities for any risk included in the RMP.
These should be considered on a case by case basis, and they will depend on
risk 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 its
effectiveness must be assessed (GVP module XVI).

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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 the
use of that medicine

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