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Session 5: UK Pharmacovigilance Requirements Post-EU Exit: Where are we now?”
Session Chair(s)
Katarzyna Okrojek-Swiderek, MPHARM, RPH
Scientific Director, Safety Evaluation Risk Management (SERM), GlaxoSmithKline, Poland
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
The UK left the EU on 31 January 2020 and the transition period ended on 31 December 2020. Initially the UK remains very highly aligned with the EU regulatory framework, free to take independent decisions in relation to Great Britain whilst remaining aligned with EU decisions in respect of Northern Ireland. This session will provide insights into the challenges and opportunities in relation to pharmacovigilance now that the UK has left the EU, through hearing the perspectives of speakers from both industry and the UK regulatory agency.
Speaker(s)
Ruth Hopper, RN
Director, Safety Governance, GSK, United Kingdom
Practical Approach to Developing a UK PSMF or Relationship Between UK QPPV and National Contact Person for Pharmacovigilance
Angela Schmidt-Mertens
EU QPPV, Eisai, Germany
Perspective of an SME on Implementing UK pharmacovigilance Requirements
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework
Stephanie Millican, PHD, MSC
Deputy Director Benefit Risk Evaluation, Safety and Surveillance, MHRA, United Kingdom
MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework
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