mindsON RBQM | Special Edition – The ICH E6 (R3) draft has landed! What does it mean for RBQM? (Webinar | Online)

Language: English

Time: 17.00 to 18.00 h (German time zone, CEST) / 11 am EDT

Price: 0 € (free of charge)

Webinar:
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.

What is a „mindsON RBQM workshop“?
mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution, performed by Cyntegrity Germany GmbH – the holistic RBQM solution provider. 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.

Who are the speakers?

• Dr. Johann Proeve (Chief Scientific Officer at Cyntegrity): Johann has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.
• Keith Dorricott, MBB (Director at DMPI Ltd): Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the MCC, such as Centralized Monitoring, eCOA, and Vendor Oversight.

Other RBQM learning resources:

Our on-demand courses for self-study and the virtual, instructor-led training courses are designed to equip risk-based clinical experts with the essential knowledge needed to be active participants in optimizing their company’s risk-based quality culture and practices. Visit the MyRBQM Academy to learn more about our courses, or contact us at academy@cyntegrity.com.

Eventdatum: Montag, 10. Juli 2023 17:00 – 18:00

Eventort: Online