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Session 5, Track B: Navigating the Quality by Design and Inspection Process for Enhanced Safety and Result Reliability of Clinical Trials
Session Chair(s)
Katalin Bertenyi, MSC
Manager, Centre for Blood, Blood Products and Biotherapeutics, Health Canada, Canada
Hocine Abid, MD, MBA
National Manager, Regulatory Operations and Enforcement Branch, Health Canada, Canada
This session is geared toward clinical trial sponsors, investigators, and study coordinators to promote Good Clinical Practices (GCP) as per the new ICH E6 R3. Speakers will provide helpful guidance on ensuring compliance with the regulatory requirements to initiate a clinical trial in Canada. The session will conclude with a Q&A period which will give participants the opportunity to ask the Health Canada representative for additional clarification.
- Navigating Good Clinical Practice Inspections with Health Canada
Kevin Donato, Health Canada - ICH E6(R3) Foundational Concepts and Overview of Selected Highlights
Katherine Soltys, Health Canada - Good Clinical Practices in the Context of the Clinical Trial Application Process
Sophie Hamel, Health Canada - Navigating Good Clinical Practice Inspections with Health Canada: Clinical Trial Compliance Program Overview
Alex Basiji, Health Canada
Learning Objective : At the conclusion of this session, participants should be able to:- Identify the key changes with ICH E6(R3), and how this will impact Health Canada and Canadians
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How to prepare a successful clinical trial application
- How to prepare for a successful regulatory GCP inspection under the GCP standard (ICH E6R3)
- Understand the key elements for a proportionate risk-based approach to inspection
Speaker(s)
Sophie Hamel, PHD, MSC
Senior Clinical Reviewer, PDD OCT, Health Canada, Canada
Good Clinical Practices in the Context of the Clinical Trial Application Process
Katherine M. Soltys, MD
Director, Office of Clinical Trials, Pharmaceutical Drug Directorate, Health Canada, Canada
ICH E6(R3) Foundational Concepts and Overview of Selected Highlights
Alex Basiji
National Director of Clinical Compliance and Border Operations, Health Canada, Canada
Navigating Good Clinical Practice Inspections with Health Canada: Clinical Trial Compliance Program Overview
Kevin Donato, PHD
Senior Compliance & Enforcement Advisor , Health Canada, Canada
Navigating Good Clinical Practice Inspections with Health Canada
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