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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)
Marie-Helene Pinheiro, PHARMD
Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency, Netherlands
Aimad Torqui
Head of Division European cooperation and veterinary affairs , MEB, Netherlands
Matthias Jauslin, PHD
Global Therapeutic Area Lead Rare Diseases, Regulatory Affairs , Novartis Pharma AG, Switzerland
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