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Session 4: Transforming Clinical Trial Design
Session Chair(s)
Maria Anillo
Regulatory Affairs Project Manager
AstraZeneca Canada Inc., Canada
A rapidly evolving clinical trial landscape has made changes to clinical trial regulations a goal for Health Canada. Ensuring that our regulatory framework can support innovative therapies as well as new clinical trial types and designs will enable clinical trials that best serve the needs of Canadians. This session will provide an overview and considerations for novel clinical trial design from the regulator and industry perspectives.
Learning Objective : - Describe the differences between adaptive designs, master protocols and decentralized trials, and how they have the potential to transform Canada’s clinical trial landscape
- Define the opportunities, challenges, and considerations for industry when applying novel techniques in clinical trials
- Define the impact and challenges that novel clinical trials designs may pose on regulators
Speaker(s)
Transforming Clinical Trial Design: Overview: Daniel L Keene, MD, MA, FRCPC
Associate Director, Office of Clinical Trials
Health Canada, Canada
Clinical Trial Design : Regulatory Challenges: Larissa M Lefebvre
Manager, Submission Management Division, OCT
Health Canada, Canada
Transforming Clinical Trial Design: Master Protocol Case Studies: Chantal MacDonald
Regulatory Affairs Project Manager
Astrazeneca, Canada
Adaptive Design Trials: Logistical Considerations for Clinical Operations: Vatche Bartekian, MSc
President
Vantage BioTrials, Canada
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