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Pharmacovigilance Strategies Workshop

Engage in the sharing of good practices between industry representatives and seek advice from regulators in this unique workshop

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

Maarten Lagendijk, MSc

  • Deputy EU QPPV
  • MSD, Netherlands
Wendy Huisman, PharmD

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)

Maarten Lagendijk, MSc

Setting the scene – Pharmacovigilance Updates

Maarten Lagendijk, MSc

  • Deputy EU QPPV
  • MSD, Netherlands
Wendy Huisman, PharmD

Setting the scene – Pharmacovigilance Updates

Wendy Huisman, PharmD

  • Director
  • Vigifit, Netherlands
Marianne Lunzer, DrMed

Deep Dive into Clinical Trial Regulation: Post-Implementation Experiences

Marianne Lunzer, DrMed

  • Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
  • AGES, Austria
Stephanie Millican, PhD, MSc

Deep Dive – PV Guidance Post Brexit

Stephanie Millican, PhD, MSc

  • Unit Manager
  • MHRA, United Kingdom

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