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Session 7, Track B: The State of ICH GCP: Moving towards Innovative Approaches in Clinical Trial Operations
Session Chair(s)
Vatche Bartekian, MSC
President, Vantage BioTrials, Canada
As we quickly approach the launch of the official ICH GCP E6 Revision 3 guidelines, the clinical trial industry and its stakeholders are making every effort to understand how the changes in R3 impact the way we work on a day-to-day basis, from the perspective of Sites, Sponsors and CROs. In this session we’ll be exploring the challenges of patient recruitment, how to be inspection-ready in light of the changes to ICH E6, and how best to utilize the principles of Quality by Design to meet the requirements of the updated guidelines.
Learning Objective : At the conclusion of this session, participants should be able to:- Tackle the challenges of participant recruitment using effective solutions
- Apply best practices on how to prepare for and undergo a regulatory inspection within the context of ICH GCP E6 (R3)
- Demonstrate how Quality by Design principles add immense value to a clinical program through actionable steps
Speaker(s)
Kerstin Koenig, PHD, MSC
Vice President, R&D Quality and Risk Management, GlaxoSmithKline, United States
QbD in Context
Ted Trafford
Director of Business Development, Probity Medical Research Inc., Canada
Enrollment is Not a Priority in Clinical Trials
Flora Noitsis
Senior Associate, Compliance & Regulatory, BioAcuity Consulting Inc., Canada
Preparing for a Clinical Trial Inspection or Audit