Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Risk Management Plan - The Legislative Changes with Directive 2010/84/EC and Regulation (EC) No 1235/2010

Dr. Karin Schlegel (Abschlußjahr: 2012)

Summary

Language: English

The new pharmacovigilance legislation Directive 2010/84/EC and Regulation (EC) No 1235/2010 brings changes regarding risk management process. Directive 2010/84/EC requires an EU-RMP for all new marketing authorisation licenses granted after 21 July 2012. A new guidance, the Guideline on Good Pharmacovigilance Practice (GVP) has been established to be in line with the legislation. The format of the EU-RMP is described in Module V of the GVP.

The advantage of an EU-RMP is the systematic overview and assessment of risk data. The integration of different aspects like epidemiology data, non-clinic and clinic data shows the risk profile of a medicinal product concerned. The prospective planning of risk minimisation activities and the systematic and regular assessment of procedures and the correction of these procedures are the aim of an EU-RMP.

A RMP should describe the knowledge of the safety profile of the medicinal product(s) concerned and the possibility to prove safety profile shown in clinical trial populations also in everyday medical practice. The need for studies on efficacy in the post-authorisation phase should also be documented.

A further objective for a RMP is to describe how to measure the minimisation of risk including how to assess the effectiveness of the risk minimisation activities.

The RMP should be updated throughout the life-cycle of the products and is a dynamic, stand-alone document which is part of the scientific dossier of a product and should be scientifically based. The update should be communicated to the authorities/Agency via variations.

With the new pharmacovigilance legislation also a new committee - PRAC - is established. The function of PRAC regarding risk management is to support the competent authorities and the Agency in questions arising for risk evaluation and its management, to assess RMP and to evaluate and monitor studies which are part of the marketing authorisation and are proposed in the RMP.

The practicability of an obligatory EU-RMP for all new marketing authorisation applications and the burden for the pharmaceutical industry and competent authorities in preparing and assessing the RMP respectively, will tell the future.

Pages: 37 pages
Annexes: 12 pages