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Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

15th Anniversary

Session 5: UK Pharmacovigilance Requirements Post-EU Exit: Where are we now?”

Session Chair(s)

Katarzyna Swiderek, MPharm, RPh

Katarzyna Swiderek, MPharm, RPh

  • Director, Safety Evaluation Risk Management (SERM)
  • GlaxoSmithKline, Poland
Kiernan Trevett, MSc

Kiernan Trevett, MSc

  • Principal Quality Lead, PDQ Quality Assurance Process GVP
  • Roche, United Kingdom
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

Practical Approach to Developing a UK PSMF or Relationship Between UK QPPV and National Contact Person for Pharmacovigilance

Ruth Hopper, RN

  • Director, Safety Governance
  • GSK, United Kingdom
Angela Schmidt-Mertens

Perspective of an SME on Implementing UK pharmacovigilance Requirements

Angela Schmidt-Mertens

  • EU QPPV
  • Eisai, Germany
Kiernan Trevett, MSc

MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework

Kiernan Trevett, MSc

  • Principal Quality Lead, PDQ Quality Assurance Process GVP
  • Roche, United Kingdom
Phil Tregunno

MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework

Phil Tregunno

  • Head of Vigilance Operations, Safety & Surveillance
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Stephanie A Millican, PhD, MSc

MHRA Update on the Operation of the UK Pharmacovigilance Regulatory Framework

Stephanie A Millican, PhD, MSc

  • Benefit_risk Unit Manager
  • MHRA, United Kingdom

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