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Session 5: UK Pharmacovigilance Requirements Post-EU Exit: Where are we now?”
Session Chair(s)
Katarzyna Swiderek, MPharm, RPh
Director, Safety Evaluation Risk Management (SERM)
GlaxoSmithKline, Poland
Kiernan Trevett, MSc
Principal Quality Lead, PDQ Quality Assurance Process GVP
Roche, 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)
Practical Approach to Developing a UK PSMF or Relationship Between UK QPPV and National Contact Person for Pharmacovigilance
Ruth Hopper, RN
GSK, United Kingdom
Director, Safety Governance
Perspective of an SME on Implementing UK pharmacovigilance Requirements
Angela Schmidt-Mertens
Eisai, Germany
EU QPPV
MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework
Kiernan Trevett, MSc
Roche, United States
Principal Quality Lead, PDQ Quality Assurance Process GVP
MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework
Phil Tregunno
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director - Patient Safety Monitoring
MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework
Stephanie Millican, PhD, MSc
MHRA, United Kingdom
Head of Immunology, Biocompatibility and Non-clinical, Safety and Surveillance
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