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Session 4: Brexit and the Consequences on Pharmacovigilance Procedures in the EU
Session Chair(s)
Joanna Harper
Expert Inspector, GPvP, Inspectorate, Enforcement and Standards
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
This session will review the current thinking and preparedness for the UK’s exit from the EU. Companies and Regulators have been working to understand and manage the operational implications of Brexit, but what do we know and what is the current thinking on how it will affect pharmacovigilance? In addition to hearing from the speakers, attendees will be encouraged to share their experience.
Speaker(s)
EMA: Timelines Worked Towards 2018 to have Everything Implemented in 2019
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
EFPIA Perspective
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
MHRA Perspective
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery