Risk Management Plan (RMP) : A New Paradigm in Pharmacovigilance

Dr Vineet Shastri, MD (Anesth.& Critical Care Medicine)

Director, PharmacovigilanceQuintiles

Disclaimer

• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to the institution, its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.  

• These PowerPoint slides are the intellectual property of the individual presenter.

• 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

Principles of Risk Management

• 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

• 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

Modules and Parts of RMPPart I Product(s) overviewPart 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 planPart IV Plans for post-authorisation efficacy studiesPart V Risk minimisation measures (including evaluation of the effectiveness of risk minimisation measures)Part VI Summary of the risk management planPart VII Annexes

Information structure in RMP

Part III- Pharmacovigilance Plan

Safety concerns

Pharmacovigilance Plan

Identify &characterise

Risk Minimization

Risk Minimization Plan

Risk Minimization Measures

Minimize & prevent risk

WHY?

EthicalDying from a disease is sometimes unavoidable; dying from a medicine is unacceptable

LegalCivil and criminal Lawsuits, imprisonments, penalties

Phamaco-econimicsADRs are expensive!! •6.5% of admissions are due to ADRs.•Cost of drug related morbidity & mortality exceeded $177.4 billion in 2000

RegulatoryRegulators expects continuous and close scrutiny and monitoring of drug safety

Thank You