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Pharmacovigilance and Risk Management Strategies Conference
Session 6: EU Updates
Michael Richardson, MD, FFPM, FRCP
- Senior Vice President, WorldWide Patient Safety
- Bristol-Myers Squibb, United Kingdom
Requirements and expectations for pharmacovigilance in the EEA continue to evolve with the objective of improving patient safety. This session will explore recent developments related to pharmacovigilance. The focus will be on the evolving situation in the EEA, set in a global context. In addition, this session will include strategic updates on Module VI and E2D (ICH) and data from PSPs; an update on “Brexit” an industry perspective from an EU perspective and a regulator perspective from the MHRA. Additionally an overview of Rev 2 of Module V (RMP) and removal of risks from RMPs.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe key new pharmacovigilance requirements in the EEA
- Understand the implications of the various Brexit scenarios
- Outline plans and contingencies for UK/EU organizational changes and Pharmacovigilance operations in the UK
Exiting the EU – The Impact on EU Pharmacovigilance Activities
- Deputy Director of Patient Safety Monitoring
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
BREXIT: Impact on Pharmacovigilance
- Vice President, Pharmacovigilance Excellence and International QPPV
- AbbVie, Inc., United Kingdom
EU Risk Management Planning GVP V (Rev2)
Valerie E. Simmons, MD, FFPM
- Senior Medical Fellow, Global Patient Safety
- Eli Lilly and Company Ltd, United Kingdom