Inspection Perspective — Tales from a Recent FDA Inspection
THURSDAY, SEPTEMBER 10th | FREE WEBINAR
30 MINUTES + Q&A | 5pm CEST | 4pm BST | 11am EDT | 8am PDT
The expectations of regulatory inspectors are rising over time - requirements are getting tighter and sponsors are expected to make better use of their systems and data. Our speaker has very relevant experience from hosting an FDA inspection (2019) where this reality was clearly illustrated.
- How this sponsor overcame a rough monitoring and documentation situation.
- What inspectors are seeking about Oversight evidence
- Their thoughts on the processes and systems used for the Trial Master File and the Investigator Study File (ISF)
- Practical steps you can take to protect your study / clinical asset even if things go awry
- Why myClin played a crucial role in "documenting the story of the story" and aiding successful navigation of that inspection.
Tales from a Recent FDA Inspection
Learn how to include local site reality in how you design your study. In this session, you will get the chance to hear from experienced site coordinators about what sites really think of your study processes. This will include how to keep your study moving during the COVID-19 pandemic.
JOIN US TO LEARN ABOUT:
-The gap between your study protocol and my clinical practice reality
-What is good (or bad) about operational practices during the pandemic
-Examples of poor study processes - and how to avoid them yourself