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Session 5, Track A: Navigating Submissions Relying on Third Party Data (SRTDs)
Session Chair(s)
Louise Blythe, MSc
Head, Regulatory Affairs
Bayer Inc. Canada, Canada
Tharany Ganesh, MSc
Head, Regulatory Affairs
AstraZeneca Canada Inc., Canada
Explore the Submissions Relying on Third Party Data (SRTD) pathway for drug registration in Canada. This session will cover Health Canada's requirements, the critical role of Systematic Literature Reviews (SLRs), and strategies for adapting foreign regulatory packages for Canadian filings. Attendees will gain essential knowledge to optimize their future SRTD submissions.
- SRTD Regulatory Pathway: Challenges, Strategic Insights, and Case Study Findings
Vishal Oza, Cencora, Innomar Strategies Inc. - SLR 4 SRTD NDS - HUH?
Brenda Gryfe, Brenda Gryfe Regulatory Consulting - The Third-Party Tightrope: Managing Third-Party Evidence in Regulatory Submissions
Torrey Parker, Health Canada
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify the essential elements required for successful Submissions Relying on Third Party Data (SRTDs)
- Acquire approaches to implement effective methodologies for conducting Systematic Literature Reviews (SLRs)
- Gain insights into developing strategic approaches for leveraging global regulatory packages in Canadian SRTD submissions
Speaker(s)
The Third-Party Tightrope: Managing Third-Party: Evidence in Regulatory Submissions
Torrey Parker, DrMed, MD, MA, FRCP
Health Canada, Canada
Acting Director, Bureau of Medical Sciences, Pharmaceutical Drugs Directorate
SRTD Regulatory Pathway: Challenges, Strategic Insights, and Case Study Findings
Vishal Oza, MPharm
Cencora, Innomar Strategies Inc. , Canada
Manager, Regulatory Affairs
SLR 4 SRTD NDS - HUH?
Brenda Gryfe, MSc
Brenda Gryfe Regulatory Consulting, Canada
Regulatory Consultant