Join us for an engaging discussion on new tools and resources for understanding the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R3) revision and its implementation. These tools are designed to help the industry adopt the latest good clinical practice (GCP) guidance, focusing on key areas of change including data governance, risk-based quality management, stakeholder collaboration, risk proportionality, and more!
During this webinar, our panelists will:
- Give you insight into key changes in ICH E6(R3) including tools to help navigate changes and use cases
- Discuss the interconnection between the ICH E6 and E8 guidelines
- Share more information about the TransCelerate and ACRO collaboration on data governance and risk management tools
Panelists:
- Shilpa Lewandowski, Director, Study Management, AstraZeneca
- Tashan Mistree, Senior Director, Business Operations, Office of Chief Medical Officer, GSK
- Madeleine Whitehead, RBQM Product & People Lead, Roche
- ACRO speaker to be announced
Ideal Attendees:
- Clinical quality
- Sponsor companies and CROs
- Academic research organizations
- Consultants
- Regulatory professionals
- Protocol specialists
- Clinical statisticians
- Clinical operations
- Patient consortia