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Brexit – Where Are We Now?
Session Chair(s)
Alan Morrison, PhD
Vice President Regulatory Affairs Intl
MSD, United Kingdom
Brexit will impact on the established European Regulatory environment over the next decade. It may create potential new opportunities for deeper integration of the operational processes of the EU Regulatory Network, however, and may also create potential risks for regulatory business continuity that could be harmful to patients. This session will provide an overview of the current state of play of the political process from a UK as well as an EU perspective. It will seek views from important healthcare stakeholder groups, such as industry, regulators and patients on the longer term impact as well as practical aspects that need to be considered to avoid unintended consequences for EU and UK citizens while fully respecting the political decisions. Multiple stakeholder perspectives will look at the post Brexit scenario from a UK perspective but also from the EU and global regulatory environment view. Key stakeholders will discuss in a panel debate the impact of the expected changes on their organisation and how they will capitalise on potential opportunities or mitigate potential risks to the regulatory business.
Speaker(s)
Panel Discussion
Virginia Acha, PhD, MSc
Merck Sharpe & Dohme LLC , United States
AVP, Global Regulatory Policy
Panel Discussion
Karl Broich, DrMed
Federal Institute for Drugs and Medical Devices (BfArM), Germany
President
Panel Discussion
Elizabeth Kuiper, MA
European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
Executive Director, Public Affairs
Panel Discussion
Jonathan Mogford
Medicines and Healthcare products Regulatory Agency (MHRA),, United Kingdom
Director of Policy
Panel Discussion
Nick Meade, MSc
Genetic Alliance UK, United Kingdom
Director of Policy
Melanie Carr
European Medicines Agency, Netherlands
Head of Stakeholders and Communication Division
Panel Discussion
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP
Drug Safety Research Unit, United Kingdom
Director
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