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Hilton Lac-Leamy

Nov 14, 2024 7:30 AM - Nov 15, 2024 4:10 PM

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

Canada Annual Meeting

The Canada Annual Meeting offers three tracks, Regulatory, Clinical, Safety and Pharmacovigilance!

Session 7, Track B: The State of ICH GCP: Moving towards Innovative Approaches in Clinical Trial Operations

Session Chair(s)

Vatche  Bartekian, MSc

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

Speaker

Kerstin Koenig, PhD, MSc

GSK, United States

Vice President, Global Quality Assurance

Ted  Trafford

Enrollment is Not a Priority in Clinical Trials

Ted Trafford

Probity Medical Research Inc., Canada

Director of Business Development

Flora  Noitsis

Preparing for a Clinical Trial Inspection or Audit

Flora Noitsis

BioAcuity Consulting Inc., Canada

Senior Associate, Compliance & Regulatory

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