Pre-Conference Sessions

25 November 2020

Full Day-Pre-Conference Session

Specific Requirements for IMPs
Facilitated by: Susanne Ding / Patryk Jegorow / Catherine Neary / Andreas Schwinn / Niina Taylor / Brenda Van Assche

  • New legislation impacting IMP QPs
  • Interactive sessions and case studies – decision making for IMP QPs
  • Phase appropriate GMP
  • IMP QP involvement in Compassionate Use, Named Patient Use and Early Access Programs
  • Use of comparators in clinical studies and IMP QP involvement
  • Identification of potential risks for IMP QPs and their mitigation strategies
  • Q&A sessions

1/2 Day Pre-Conference Session

Human Error
Facilitated by: Sue Mann / Kristina Smith Hansen

  • What is behind “Human Error”?
  • Considering human behaviours
  • Is Human error avoidable?
  • Tips for reducing human errors

1/2 Day Pre-Conference Session

Serialisation re-revisited
 Facilitated by: Afshin Hosseiny / Ulrich Kissel

More than twenty months after implementation and still challenging: Discuss occurring challenges and the impact on the QP’s daily life and find answers and solutions.

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