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Europe Town Hall

Track:
Global Regulatory

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
251

Room Number:
6F

Level:
Intermediate

Type:
Forum

Title:
Europe Town Hall

Chair(s):
Guido Rasi, MD
Executive Director
European Medicines Agency, European Union, United Kingdom

Description:
The European Union regulatory network, including the European Medicines Agency, national agencies in the Member States and European Commission, has developed a range of initiatives and entry points to facilitate regulatory procedures and scientific dialogue from early development to postmarketing authorization stages. In addition to discussing some of the scientific and regulatory challenges facing regulators and industry in Europe, the forum will showcase what is being done to support biopharmaceutical R&D, in particular through the Innovative Medicines Initiative (IMI), benefiting both industry and public health. This forum offers the opportunity to interact directly with senior leadership from the European Medicines Agency, national medicines agencies, and the IMI regarding recent initiatives.

Please come prepared with your questions for the EU Town Hall panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.org, and include “EU Town Hall” in the subject line.

Learning Objective(s):
Summarize key issues discussed by the EMA , national medicines agencies and the IMI; Identify scientific and regulatory challenges facing regulators and industry in Europe.

Presentation(s) & Speaker(s):
Panelist
Hans-Georg Eichler, MD, MSc
Senior Medical Officer
European Medicines Agency, European Union, United Kingdom

The Innovative Medicines Initiative: Fostering Therapeutic Innovation Through Multi-Stakeholder Collaboration
Michel Goldman, MD, PhD
Executive Director
Innovative Medicines Initiative (IMI), Belgium

Panelist
Christa Wirthumer-Hoche, PhD
Head, Austrian Medicines and Medical Devices Agency
Austrian Medicines and Medical Devices Agency (AGES), Austria