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Session 6: Hot Topics - The Rapid-Fire Rundown
Session Chair(s)
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Session Overview: The Hot Topics session provides insights in the very latest on discussions in specific Safety areas of interest. The expert speakers that lead these discussions will share information on these key topics, the issues at hand, the progress that is being made and what the audience can expect on these topics for the future. The topics will be of interest to a broad audience and will be of specific value to participants that are not able to attend Industry Association meetings or public meetings with EMA due to limited attendance possibilities.
Speaker(s)
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Implementing Regulation, Risk Management Plan Template revision and Targeted Follow-Up Questionnaires
Raphael Van Eemeren
EU QPPV Senior Director, Global Patient Safety, Amgen AB, Sweden
Update on E2D
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
UK Updates: Decentralized Manufacturing, CTR 2026 and UK MDR PMS
Peter De Veene, MD
QPPV, MSD Belgium, Belgium
Follow Up Initiative
Jason Burns
Data Protection Officer (EU/EEA, UK and Switzerland), Bristol Myers Squibb, Ireland
Privacy and Patient Safety Update
Raphael Van Eemeren
EU QPPV Senior Director, Global Patient Safety, Amgen AB, Sweden
Data Masking Guideline
Andreia Dinis
Associate Director, Safety Compliance Intelligence & Policy, AbbVie, Portugal
AI in PV Updates
Peter De Veene, MD
QPPV, MSD Belgium, Belgium
Module XVI: Best Practices