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CCH - Congress Center Hamburg

2016年4月06日 (水) 午前 9:00 - 2016年4月08日 (金) 午後 5:30

Am Dammtor / Marseiller Str., 20355 Hamburg, Germany

28th Annual EuroMeeting

Improving Global Health: How Can Regulators Help?

Session Chair(s)

Emer  Cooke, MBA, MSC

Emer Cooke, MBA, MSC

Chair, ICMRA; Executive Director

European Medicines Agency, Netherlands

Regulators play an important role in the protection and promotion of public health. Regardless of where they are in the world, they face similar challenges, but not all are equipped or resourced to respond in the same way. This session will explore various global and regional initiatives that aim to strengthen and build regulatory capabilities through benchmarking and establishing good regulatory practices: Using EMA Article 58 procedure not only to give scientific assessments but also as a tool for capacity building and training; and increasing harmonisation between regulators to increase collaboration and reliance.

Speaker(s)

Petra  Doerr, PHARMD, RPH

Reinforcing Common Standards: International Harmonisation, Collaboration and Reliance Initiatives

Petra Doerr, PHARMD, RPH

European Directorate for the Quality of Medicines and Healthcare (EDQM), France

Director

Emer  Cooke, MBA, MSC

Helping to Provide Scientific Assessment and Building Capacity outside the EU (Collaboration with WHO and EMA Article 58)

Emer Cooke, MBA, MSC

European Medicines Agency, Netherlands

Chair, ICMRA; Executive Director

Michel  Stoffel, DrMed

Opportunities and Challenges for Industry to Help Regulators

Michel Stoffel, DrMed

Glaxosmithkline Biologicals SA, Belgium

Vice-President, Head Europe Region, Global Regulatory Affairs

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