Back to Agenda
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)
Daniel L Keene, MD, MA, FRCPC
Associate Director, Office of Clinical Trials , Health Canada, Canada
Transforming Clinical Trial Design: Overview
Larissa M Lefebvre
Manager, Submission Management Division, OCT, Health Canada, Canada
Clinical Trial Design : Regulatory Challenges
Chantal MacDonald
Regulatory Affairs Project Manager, Astrazeneca, Canada
Transforming Clinical Trial Design: Master Protocol Case Studies
Vatche Bartekian, MSC
President, Vantage BioTrials, Canada
Adaptive Design Trials: Logistical Considerations for Clinical Operations
Have an account?