The FDA has just published a "Guidance for Industry" - a Question and Answer guide to supplement the 2013 Guidance "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring." The 2013 Guidance sent shockwaves through the industry. It led, with other regulators, to the 2016 addendum to ICH E6, including a risk-based approach to monitoring and introducing the concept of centralized monitoring. So what is this new Guidance? And what are the implications? We'll take you through the document and our interpretation, and there will be an opportunity for attendees to provide their perspectives and for us to learn together.
Chapters:
00:00 Webinar Introduction
3:06 FDA Guidelines Introduciton
5:29 Where to Find It?
5:53 Poll Question
8:20 Areas of the Guidance That Stand Out
11:25 Quality by Design
12:18 New Guidelines' FAQs
13:25 Risk Assessment
18:53 Risk Monitoring
22:02 Considering Factors to Monitoring Activities
26:10 Risk-Based Monitoring
34:33 Maintaining Appropriate Study Blindness
37:35 Elements of a Monitoring Plan
40:33 Follow-Up on Significant Issues
43:08 Documenting & Communicating Monitoring Activities
45:43 Key Takeaways
53:57 Summary
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Welcome to mindsON RBQM, a tailor-made workshop series crafted to empower you in navigating the complexities of Risk-Based Quality Management (RBQM) implementation and daily execution. Each engaging session offers practical guidance, interactive discussions, and hands-on problem-solving exercises, allowing you to actively participate and share your unique experiences. Whether you prefer to dive into lively conversations or observe and absorb valuable insights, mindsON RBQM has something for everyone.
For a personalized learning experience, explore our diverse range of programs, instructor-led and on-demand courses available at the Cyntegrity Academy website: academy.cyntegrity.com.
Next mindsON RBQM workshop: May 31, 5 pm CEST / 11 AM EDT
5 авг 2024
