This document discusses risk management plans (RMPs), which are detailed descriptions of risk management systems for pharmaceutical products that are required by the European Union. RMPs identify, characterize, minimize and prevent risks related to medicinal products. They contain modules on safety specifications, pharmacovigilance plans, post-authorization efficacy study plans, and risk minimization measures. RMPs must be submitted with new marketing authorization applications, in response to significant new safety concerns identified by health authorities, or when changes are made to the RMP as a result of data in periodic safety update reports. The goal of RMPs is to ensure patient safety by continuously monitoring pharmaceutical products for adverse drug reactions.

1. Risk Management Plan (RMP) : A New
Paradigm in Pharmacovigilance
Dr Vineet Shastri, MD
(Anesth.& Critical Care Medicine)
Director, Pharmacovigilance
Quintiles

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3. • Risk Management Plan (RMP)
– A detailed description of the risk management system [DIR
Art 1(28c)]
• Risk management system
– US A set of pharmacovigilance activities and interventions
designed to identify, characterise, prevent or minimise risks
relating to medicinal products including the assessment of
the effectiveness of those activities and interventions [DIR
Art 1(28b)]
Definition

4. Principles of Risk Management

5. • Directive 2001/83/EC
– Article 8 (3), Article 21a, Article 22a, Article 22c, Article
104, Article 106(c), Article 127a
• Commission Implementing Regulation (EU) No. 520/512
– Article 30, Article 31, Article 32, Articles 33, Annex 1
• Regulation (EC) No 726/2004
– Article 6, Article 9(4), Article 10a, Articles 23(3), Article
26(c)
• Regulation (EC) No 1901/2006
– Article 34
• Regulation (EC) No 1394/2007
– Article 14
Legal Basis

6. • With an application involving a significant change to an existing
marketing authorisation
– new dosage form
– new route of administration
– new manufacturing process of a biotechnologically-derived
product
– Paediatric indication
– Other significant change in indication
• At the request of health authorities upon identifying a significant
new safety concern
• With a PSUR for single centrally authorised medicinal product,
when the changes to the RMP are a direct result of data presented
in the PSUR
When

7. Modules and Parts of RMP
Part I Product(s) overview
Part II Safety specification
– Module SI Epidemiology of the indication(s) and target population(s)
– Module SII Non-clinical part of the safety specification
– Module SIII Clinical trial exposure
– Module SIV Populations not studied in clinical trials
– Module SV Post-authorisation experience
– Module SVI Additional EU requirements for the safety specification
– Module SVII Identified and potential risks
– Module SVIII Summary of the safety concerns
Part III Pharmacovigilance plan
Part IV Plans for post-authorisation efficacy studies
Part V Risk minimisation measures (including evaluation of the effectiveness
of risk minimisation measures)
Part VI Summary of the risk management plan
Part VII Annexes

8. Information structure in RMP

9. Part III- Pharmacovigilance Plan
Safety concernsSafety concerns
Pharmacovigilance PlanPharmacovigilance Plan
Identify &
characterise

10. Risk Minimization
Risk Minimization PlanRisk Minimization Plan
Risk Minimization MeasuresRisk Minimization Measures
Minimize &
prevent risk

13. WHY?
Ethical
Dying from a disease is sometimes
unavoidable; dying from a medicine
is unacceptable
Legal
Civil and criminal Lawsuits,
imprisonments, penalties
Phamaco-econimics
ADRs are expensive!!
•6.5% of admissions are due to ADRs.
•Cost of drug related morbidity & mortality exceeded $177.4 billion
in 2000
Regulatory
Regulators expects continuous and
close scrutiny and monitoring of
drug safety

14. Thank You