UK National QPPV Workshop

This face-to-face workshop is designed for QPPVs, whether based in the UK or EU, and National Contact Persons for PV to meet and share experiences and best practices across a range of type and size of companies, and also to hear the perspective from the MHRA.

Back to Agenda

Session 2 - Part I: Practical Approaches to UK Pharmacovigilance Processes

Session Chair(s)

Louise Woodward, PhD

UK QPPV and Local Safety Responsible

Roche Products Ltd, United Kingdom

Sina Schader, DrMed

Head of QPPV Office and EU QPPV

AbbVie, Germany

This informative and interactive session will take a deep dive into practical aspects of pharmacovigilance (PV) procedures at the MHRA and EMA. Learn about the latest updates in PV guidances and what the MHRA expects from industry players through real-life case studies. Get a deeper understanding of the PV process by examining real-world examples of topics that include submissions of PSURs, ICSRs and Risk Management Plan annexes.

Speaker(s)

Submission of PSURs – MHRA Expectations

Stephanie Millican, PhD, MSc

MHRA, United Kingdom

Deputy Director Benefit Risk Evaluation, Safety and Surveillance

Submission of PSURs – Practical Case

Cleo Fu

Alliance Pharmaceuticals Limited, United Kingdom

UK QPPV

RMP Annexes - Practical Cases

Chia Yin Lim