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European Town Hall: Implementation of New Safety Legislation and Other Hot Topics
Session Chair(s)
Martin Harvey Allchurch, LLM
Head of International Affairs
European Medicines Agency, Netherlands
The new pharmacovigilance legislation came into force in July 2012. The new Pharmacovigilance Risk Assessment Committee (PRAC) started work in July 2012. The focus in this forum will be on the first experiences with the new PRAC and how the PRAC interacts with the different EU committees (such as the CHMP and CMDh.) The new legislation has increased the transparency on early announcements of safety referrals and publication of agendas and minutes of different scientific committees. Also new is the possibility for a public hearing. What has been the response from the patients and general public to this increase in transparency? Regarding benefit-risk assessment pre- and postlicensing, does the new legislation provide better tools to generate data to assess benefit-risk of new medicines on an ongoing basis?
Speaker(s)
Panelist
Christa Wirthumer-Hoche, PHD
Austria
Retired
Panelist
Aginus A. W. Kalis, MD
CIBG , Netherlands
Director
Panelist
Hans-Georg Eichler, MD, MSC
Austrian Association of Social Security Bodies, Austria
Consulting Physician