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Session 1: Pharmacovigilance Update – Introduction, Overview and Deep-dive – What You Always Wanted to Know but Were Afraid to Ask
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV
MSD, Netherlands
Wendy Huisman, PharmD
Director
Vigifit, Netherlands
In this opening session we will get to know each other, and find out who we are, what we know of PV and which topics are especially important to you. Pharmacovigilance is always changing, and to set the stage and get everyone up to speed, a quick overview of important changes to PV guidance and regulations will be provided. Supported by expert speakers we will then take a deep-dive into two of the more impactful recent changes: the Clinical Trial Regulation (EU CTR) and the post-Brexit guidance in the UK. The session will be interactive with plenty of possibilities to ask questions, challenge the panel or each other and to share experiences.
Speaker(s)
Setting the scene – Pharmacovigilance Updates
Maarten Lagendijk, MSc
MSD, Netherlands
Deputy EU QPPV
Setting the scene – Pharmacovigilance Updates
Wendy Huisman, PharmD
Vigifit, Netherlands
Director
Deep Dive into Clinical Trial Regulation: Post-Implementation Experiences
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
Deep Dive – PV Guidance Post Brexit
Stephanie Millican, PhD, MSc
MHRA, United Kingdom
Head of Immunology, Biocompatibility and Non-clinical, Safety and Surveillance
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