Name
Operating in a World of Grey for Non-interventional/Real World Evidence Studies
Date & Time
Monday, October 21, 2024, 2:30 PM - 3:30 PM
Track
Quality / Regulatory
Description
The session will take a look into how we can ensure quality and compliance in NIS trials; how to apply GPP and GCP in a grey environment of NIS. Developing a robust QMS for NIS trials including audit plans, quality controls and risk management factors.
Speakers
Jennifer Peterson - Director, Head of Clinical Quality - M3 Wake Research
Alexandra Altland - Associate Director, Non-interventional QMS - Merck
Tara Isherwood - Senior Director, Regulatory Advice and Delivery - Syneos
Alexandra Altland - Associate Director, Non-interventional QMS - Merck
Tara Isherwood - Senior Director, Regulatory Advice and Delivery - Syneos
