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Wednesday, June 27 • 4:00pm - 5:00pm
#394: Update on BREXIT

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-705-L04-P; CME 1.00; IACET 1.00

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 Objectives

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.

Chair

Agnès Saint-Raymond, MD

Speaker

Panelist
Marie-Helene Pinheiro, PharmD

Industry Perspective
Aimad Torqui, MSc

Industry Perspective
Matthias Jauslin, PhD


Speakers
MJ

Matthias Jauslin

Global Therapeutic Area Lead Rare Diseases, Regulatory Affairs, Novartis Pharma AG
Matthias Jauslin is working as a global therapeutic area lead in regulatory affairs at Novartis Pharma AG in Basel, Switzerland. He is managing a group of professionals who are responsible for the regulatory aspects of medicinal products developed for rare diseases. Matthias Jauslin... Read More →
avatar for Marie-Helene Pinheiro

Marie-Helene Pinheiro

Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency (EMA)
Marie-Helene Pinheiro currently the Industry Stakeholder Liaison within the Corporate Stakeholders Department, at the European Medicines Agency. She is responsible for coordinating the Agency’s interaction with industry stakeholder organisations, for human and veterinary medicines... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
AT

Aimad Torqui

Director Global Regulatory Policy, MSD
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment includes Medicines Evaluation Board and Novartis Vaccines. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.

Wednesday June 27, 2018 4:00pm - 5:00pm
Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum