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mindsON RBQM | Special Edition: The ICH E6 R3 Draft - what does it mean for RBQM?

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. ------- 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: https://academy.cyntegrity.com/upcomi...