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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
VP Quality and Patient Safety, Avanzanite Bioscience, 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)
Maarten Lagendijk, MSc
Deputy EU QPPV, MSD, Netherlands
Setting the scene – Pharmacovigilance Updates
Wendy Huisman, PharmD
VP Quality and Patient Safety, Avanzanite Bioscience, Netherlands
Setting the scene – Pharmacovigilance Updates
Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
Deep Dive into Clinical Trial Regulation: Post-Implementation Experiences
Stephanie Millican, PhD, MSc
Deputy Director Benefit Risk Evaluation, Safety and Surveillance, MHRA, United Kingdom
Deep Dive – PV Guidance Post Brexit
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