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Improving Global Health: How Can Regulators Help?
Session Chair(s)
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)
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
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
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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