GAIN REGULATORY INSIGHTS2025 BIOLOGICS & BIOSIMILAR SYMPOSIUM
Friday, March 28, 2025 | TORONTO
Friday, March 28, 2025 | TORONTO
Join CAPRA's Biologics & Biosimilar event with Health Canada and Industry Leaders.
This collaborative event represents a valuable opportunity to acquire insights and regulatory knowledge that will assist our regulatory professionals in navigating the complexities of scientific developments and advancements.
By attending, you will gain practical regulatory insights through in-person Q&A and panel discussions with all speakers by attending.
2025 Biologics and Biosimilar Symposium
Don't miss the chance to enhancing your professional knowledge and skills!
Join CAPRA's Biologics and Biosimilar event with Health Canada and Industry leaders. This collaborative event represents a valuable opportunity to acquire insights and regulatory knowledge that will assist our regulatory professionals to navigate the complexities of scientific developments and advancements.
By attending, you will gain practical regulatory insights through in-person Q&A and panel discussions with all speakers.
- Opening remarks from BRDD Director General
- Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products
- Update on ICH M4Q (R2) CTD guidance
- Biosimilar Guidance Update
- Discussing the 15-day Clarifax timelines for submitting samples with HC
- Agile Licensing of Drugs and Medical Devices regulations
- BIOTECanada Overview
- Update on ATP
- From Foundations to Frontiers: The Evolving Landscape of Biologics Regulations
- Strategies to Overcome Development and Regulatory Challenges for Small and Medium Companies
Symposium Speakers
Sophie Sommerer
Health Canada
Director General, BRDD
Hugo Hamel
Health Canada
Associate Director, CBBB, BRDD
Denis Arsenault
Health Canada
Manager, Centre for Policy, Pediatrics and International Collaboration
Dr. Chris Ablenas
Health Canada
Senior Evaluator, CBBB, BRDD
Amy Tsung
Sanofi Canada
Head, Regulatory Affairs, CMC
Fiona Frappier
Health Canada
Manager, Centre for Policy, Pediatrics and International Collaboration
Ron Boch
BIOTECanada
Vice President, Biotechnology and Industry Affairs
Johanne Veenstra
Health Canada
Senior Regulatory Policy and Risk Management Advisor, Office of Advanced Therapeutic Products,
Jennifer Wilhelm
Merck Canada
Director, Regulatory Affair
Yatika Kohli
NoNo Inc.
Chief Regulatory
and Strategy Officer
Ryan van Bendegem
AstraZeneca Canada
Senior Manager for CMC,
Regulatory Affairs
Jody Cox
Biosimilars Canada
Vice President
Agenda
Thank You to Our Sponsors
We want to extend our heartfelt gratitude to the sponsors of the 2025 Biologics and Biosimilar Symposium. Your commitment not only helps us bring together the brightest minds in the pharmaceutical and regulatory fields but also ensures the continued success of these knowledge-sharing platforms. Together, we are driving innovation, fostering collaboration, and shaping the future of the industry.
Click on our sponsors' logos to view more resources.
