25th Annual EuroMeeting

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FIRST EXPERIENCE WITH THE PHARMACOVIGILANCE LEGISLATION

Session Chair(s)

Isabelle Stoeckert, PharmD, PMP

VP. Head Regulatory Affairs Europe Middle East Africa PH

Bayer, Germany

The new Pharmacovigilance legislation is the biggest change to the regulation of human medicines in the European Union since 1995. This session will focus on how the different stakeholders in the European Regulatory Network interact. Does communication and co-operation work? What are the first experiences?

Speaker(s)

New Tasks for CMDh – How do the new pharmacovigilance processes work?

Peter Bachmann

Federal Institute for Drugs and Medical Devices (BfArM), Germany

Deputy-Head, European Union and International Affairs

Sharing Perspectives in a Complex Environment – CHMP´s first experiences with the new pharmacovigilance processes

Tomas Salmonson, DrMed, PhD

Critical Path Institute, United States

Partner

First Experiences with the New Pharmacovigilance Processes in Close Interaction with CHMP and CMDh – the PRAC perspective

George Aislaitner

National Drugs Organization of Greece, Greece

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