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Session 2: Pharmacovigilance Changes In The UK
Session Chair(s)
Shahin Kauser
Leading Senior Scientific Assessor
MHRA, United Kingdom
This session will cover the new requirements for pharmacovigilance procedures such safety signals, safety reviews, variations, Periodic Safety Update Reports (PSUR) and Risk Management Plans in the UK following the end of the Brexit transition period. A regulator and the industry perspective will be given. The session aims to provide delegates with professional working knowledge of the UK PV requirements and an overview of the processes and procedures to help ensure compliance. Delegates will also have the opportunity to submit questions for the panel discussion at the end.
Speaker(s)
PV and Risk Management planning developments in the UK - Industry Perspective
Anne M Ambrose, MPharm, MSc, RPh, RAC
Medicines & Healthcare Products Regulatory Agency, United Kingdom
Specialist in Post Authorisation Operations and Safety Issues
Variations between Northern Ireland and Great Britain: Industry Perspective
Paul Knights
Pfizer, United Kingdom
Senior Director, Head Pharmacovigilance Strategy Policy & Standards and UK QPPV