The industry has been waiting with bated breath for the update to E6. And now we have the draft E6 (R3) open to public consultation. So what are the implications for RBQM? Can we forget about QTLs? Is on-site monitoring and 100% SDV the gold standard? Join our RBQM experts, Johann and Keith, as they give their perspective on the new draft of GCP and how it might impact RBQM in a Special Edition of the popular mindsON RBQM series.
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Chapters:
0:00 Webinar Introduction
1:09 Speakers Introduction
3:18 Topic Introduction
5:29 ICH E6 Document Development Progress
6:50 Poll Question
10:35 Why Is There an Update?
12:19 Quality by Design Focus
14:10 Risk-Adapted Approaches
15:52 Poll Question
20:06 Section 3.10
21:37 Section 3.10 - Quality Management
23:46 Section 3.10 - Preamble and Risk ID
25:59 Section 3.10 - Risk Evaluation
34:36 Section 3.10 - Risk Management in Medical Devices
36:55 Section 3.10 - Risk Control
38:36 Poll Question
41:00 Section 3.10 - Risk Communication, Review & Reporting
41:50 Other Relevant Changes for RBQM
48:12 Helpful RBQM Changes
54:27 Challenging RBQM Changes
58:01 Summary
59:18 Q&A
About "mindsON RBQM" workshops: mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.
Next mindsON RBQM workshop:
Sept. 11, Episode 17: Developing the critical skill of data analysis
90 min. episode, starts at: 11 AM ET / 5 PM CET
Learn more: academy.cyntegrity.com/upcomi...
5 июл 2024
