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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)
Anabela Marcal, PHARMD
EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
EMA: Timelines Worked Towards 2018 to have Everything Implemented in 2019
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
EFPIA Perspective
Mick Foy
Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
MHRA Perspective