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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.