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Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work. Anniversary edition: 5 years


Session 2: Pharmacovigilance Changes In The UK

Session Chair(s)

Shahin  Kauser

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)

Anne M Ambrose, MPharm, MSc, RPh, RAC

PV and Risk Management planning developments in the UK - Industry Perspective

Anne M Ambrose, MPharm, MSc, RPh, RAC

  • Specialist in Post Authorisation Operations and Safety Issues
  • Medicines & Healthcare Products Regulatory Agency, United Kingdom
Paul  Knights

Variations between Northern Ireland and Great Britain: Industry Perspective

Paul Knights

  • Senior Director, Head Pharmacovigilance Strategy Policy & Standards and UK QPPV
  • Pfizer, United Kingdom