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Safety reports rmp risk management plan pharmacovigilance


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A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.

Published in: Science
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Safety reports rmp risk management plan pharmacovigilance

  1. 1. Safety Reports: RMP: Risk Management Plan
  2. 2. 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
  3. 3. 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
  5. 5. 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.
  6. 6. 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.
  7. 7. 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.
  8. 8. 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.
  9. 9. 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.
  10. 10. 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.
  11. 11. 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
  12. 12. a. General Overview of the medicine
  13. 13. 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
  14. 14. 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
  15. 15. 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.
  16. 16. 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).
  17. 17. 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
  18. 18. We are safety experts, if you want to get to know us better visit us on: Azierta O síguenos en: Azierta @Azierta