European Town Hall: Implementation of New Safety Legislation and Other Hot Topics
Track
:
Track 18: Global Regulatory
Program Code:
122
Date:
Monday, June 24, 2013
Time:
11:00 AM to 12:30 PM
EST
Location:
257AB
CHAIR
:
Martin Harvey-Allchurch, Esq, LLM (SCHAGY), Head of Communications, European Medicines Agency, European Union, United Kingdom
Law degrees from University of Dundee, UK, and Vrije Universiteit Brussel, Belgium.
European affairs consultant in Brussels from 1992 to 1995. Joined EMEA in September 1995. Nominated as Agency spokesman in September 2001 and appointed Head of Executive Support in January 2004.
SPEAKER
(S):
Hans-Georg Eichler, MD,MSc (SPKAGY), Senior Medical Officer, European Medicines Agency, European Union, United Kingdom
Before becoming Senior Medical Officer, Dr Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research. His industry experience includes UK Ciba-Geigy and US Merck & Co
Christa Wirthumer-Hoche, PhD (SPKAGY), Member CMDh, Head of Institute, Deputy Head of Austrian Medicines and Medical Devices Agency (AGES), Austria
Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of Licensing of Med Products and Deputy Head of the Austrian
Dr Aginus Kalis is Executive Director of the Medicines Evaluation Board in the Netherlands, Member of the Management Board of the European Medicines Agency (EMA) in London (UK), and Chairman of the Heads of Medicines Agencies Management Group.
Description
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?