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Le Palais des Congrès

Apr 13, 2015 9:00 AM - Apr 15, 2015 5:30 PM

2, Place de la porte Maillot, F-75017 Paris, France

27th Annual EuroMeeting

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PRAC: HIGHLIGHTS, CHALLENGES AND REFERRALS

Session Chair(s)

Sarah Montagne

Sarah Montagne

Head UK/IE Regulatory Affairs

Bayer plc, United Kingdom

Sabine Straus, MD, PhD, MSc

Sabine Straus, MD, PhD, MSc

PRAC Chair, Staff Member

Medicines Evaluation Board (MEB), Netherlands

The Impact of Imposed PASS and the Challenges of Making Multi-MAH Studies Work

Learning Objective : You will be able to recognise the impact and difficulties of organising Post Authorisation Safety Studies (PASSes) for the pharmaceutical industry when multiple Marketing Authorisation Holders are involved. This session will describe how work sharing is carried out currently and how it can be improved.

Speaker(s)

Panel Discusion

Jean-Michel Dogne

University of Namur, Agence Fédérale Des Médicaments Et Des Produits De Santé, Belgium

Georgy Genov, MD

PRAC: Highlights from a busy agenda

Georgy Genov, MD

European Medicines Agency, Netherlands

Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department

The Impact of Imposed PASS and the Challenges of Making Multi-MAH Studies Work

Katarina Nedog, MSc

EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

Associate Director

Union Safety Referrals: Shared experiences of the referral journey for well-established products and the importance of effective communication

Emmanuelle Pines, MD

Pierre Fabre, France

Directeur Vigilances Monde/ Head of Corporate Vigilances Division 45

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