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Session 4, Track B: Key Changes to the ICH E6 R3 Guidelines
Session Chair(s)
Vatche Bartekian, MSC
President, Vantage BioTrials, Canada
Marie-France Goyer, MSC
Senior Director, Clinical Operations, Abcellera, Canada
Émilie Lévesque, MSC
Senior Clinical Quality Manager, Abcellera, Canada
Kim McDonald-Taylor, MS, MSC
Clinical Research Consultant, Clinical Research Association of Canada Inc., Canada
ICH E6(R3) draft is now available but it has been completely reformatted. We will walk you through some of the key changes and point out some of the great things that have remained.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize the key changes in revision 3
- Identify how to utilize these changes in your day to day activities
- Summarize the key changes to your colleagues
Speaker(s)
Kim McDonald-Taylor, MS, MSC
Clinical Research Consultant, Clinical Research Association of Canada Inc., Canada
Key Changes to the ICH E6 Guidelines: R2 to R3
Sabrina Ramkellawan
President and Board Director, Clinical Research Association of Canada, Canada
Key Changes to the ICH E6 Guidelines: R2 to R3