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Update on BREXIT
Session Chair(s)
Agnès Saint-Raymond, DrMed
Head of Division International Affairs
European Medicines Agency, Netherlands
Since the United Kingdom’s notification to the European Council of decision to withdraw from the EU (Brexit) in March 2019, the EMA has been making preparations to ensure continuity of its mission to protect public and animal health under the new structure. In this session, EMA representatives will discuss the status of regulatory and operational preparedness plans, including the EMA’s move to Amsterdam, and the impact of Brexit-related changes on US and EU companies. European industry stakeholders will share their perspectives on the adjustment to the coming changes.
Learning Objective : Gain insights on EMA guidances reflecting pending regulatory changes resulting from Brexit; Describe details of EMA operational preparations and coming changes resulting from Brexit; Discuss the impact of pending changes on US, EU, and UK biopharmaceutical companies.
Speaker(s)
Panelist
Marie-Helene Pinheiro, PharmD
European Medicines Agency, Netherlands
Industry Stakeholder Liaison, Corporate Stakeholders Department
Industry Perspective
Aimad Torqui
Medicines Evaluation Board, Netherlands
Division Head Medicines Evaluation Board
Industry Perspective
Matthias Jauslin, PhD
Novartis Pharma AG, Switzerland
Global Therapeutic Area Lead Rare Diseases, Regulatory Affairs
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