THE EU RISK
MANAGEMENT PLAN

Conference Date: 15 May 2009-15 Jun 2009
Conference Ref: A5-1009
Fee: £550 + VAT
Venue: The Cavendish Hotel, London

Topics to be covered include: 

• The EU Risk Management Plan in the context of global risk management
• Case Study; Development of Risk Management Plan for a Product with a Major Safety Issue
• The EU Risk Management Plan: Legislation and Guidance - What’s required?
• Experience and problems
• Incorporation of risk management activities into the drug development programme
• Workshop on the development of a Risk Management Plan for the further investigation of known and potential risks of a newly approved product.

Chairman:
Dr Patrick Salmon
Senior Medical Officer, Irish Medicines Board

Speaker:
Dr Glyn Belcher
Senior Director of Drug Safety & Risk Management, Biogen Idec Ltd.

WHY YOU SHOULD ATTEND

This Seminar will explain the regulatory requirements for Drug Safety Risk Management in the Risk Management Plan, and offer practical advice for its development and implementation.   It will include a workshop to discuss the approach of industry and the regulators in the development of a risk management plan for the further investigation of known and potential risks of a newly approved product.

WHO SHOULD ATTEND 

This Seminar is aimed at personnel in pharmaceutical departments of research and development, pre- and post marketing pharmacovigilance, clinical, registration and regulatory affairs.  It will also be of interest to those working in drug safety, risk management and strategic planning.