businessHosted by Canadian Association of Professionals in Regulatory Affairs (CAPRA)

The CAPRA 2026 Regulatory Affairs Symposium is a two-day event bringing together Health Canada representatives and regulatory affairs professionals from the pharmaceutical and life sciences industries. Day one focuses on regulatory modernization, international harmonization, regulatory technology, artificial intelligence, electronic submissions, FHIR and APIs. Day two explores regulatory submission quality, review efficiency, generic medicines, biologics, biosimilars and collaboration between regulators and industry. The symposium includes expert presentations, interactive discussions and opportunities for direct engagement with Health Canada.
Date
Time
12:00 AMVenue
Toronto
Canada
Hosted By
Canadian Association of Professionals in Regulatory Affairs (CAPRA)
Kelly Robinson
Director General, Pharmaceutical Drugs Directorate, Health Canada
Mark Gray
Senior Adviser, Submission Strategy, LORENZ Life Sciences Group
Laurent Lefebvre
Toronto, Canada | The Westin Toronto Airport, 950, Dixon Road, West Humber-Clairville, Etobicoke North, Etobicoke, Toronto, Ontario, M9W 5N4, Canada
Head, RA Data & Technology, Novartis
Ron Fitzmartin
Principal Consultant, Decision Analytics, LLC
Craig Anderson
Business Product Director, Labelling, Johnson & Johnson
Lorelle Leonienco
Executive Lead, Government & Regulatory Intelligence, LORENZ Life Sciences Group
Khaled Yahiaoui
Associate Director, Regulatory Operations, Merck Canada
Tim MacDonald
Project Lead, Enablement of Artificial Intelligence, Health Products and Food Branch, Health Canada
Seema Verma-Pharasi
Executive Director, Health Products and Food Branch, Health Canada
Irena Pastorekova
Regulatory Enablement Services and Business Facilitation and Modernization Directorate, Health Canada
Katerina Paschakis
Manager, Project Portfolio Management Office, Health Products and Food Branch, Health Canada
Nadine Mukri
Regulatory Operations Professional
Veronica Yip
Manager, Labelling Division, Pharmaceutical Drugs Directorate, Health Canada
Amanda Starr
Clinical Scientific Evaluator, Metabolic and Musculoskeletal Drugs Division, Health Canada
Michaël Cardinal
Co-Founder and CEO, AppGuide (formerly TherAppX)
Charles Mathis
Regulatory Solutions Architect, LORENZ Life Sciences Group
Andrée-Anne Chevalier
President, Vigilance Santé
Joe Mikhael
Manager, Digital Regulatory Operations Section, Health Products and Food Branch, Health Canada
Tracy Brown
Senior Project Manager, Business Facilitation and Modernization Directorate, Health Canada
Michael Wood
Senior Regulatory Information Officer, Health Canada
Tanya Ramsamy
Interim Director, Bureau of Pharmaceutical Sciences, Pharmaceutical Drugs Directorate, Health Canada
Christiane Grisé-Bard
Associate Director, Bureau of Pharmaceutical Sciences, Health Canada
Betty Cory
President and Co-Founder, Regxia Inc.
Lori deMunnik
Vice President and Co-Founder, Regxia Inc.
Kristin Willemsen
Vice President, Scientific & Regulatory Affairs, Canadian Generic Pharmaceutical Association
Elana Cherry
Director, Centre for Blood, Blood Products and Biotherapeutics, Health Canada
Amy Tsung
CMC Group Manager, Regulatory Affairs, GSK Canada
Sukhvir Hundal
Head of Regulatory Affairs, Biocon Biologics Canada; Co-Chair, Biosimilars Canada Science Committee
Denise David
Vice President, Scientific Affairs, Kye Pharmaceuticals
Dalia Haddad
Senior Advisor, Health Product Compliance Directorate, Health Canada
Rachel Hanna
Senior Evaluator, Biologic and Radiopharmaceutical Drugs Directorate, Health Canada
Robert Mitchell Baldwin
Senior Clinical Evaluator, Clinical Evaluation Division-Oncology and Radiopharmaceuticals, Health Canada
Melissa Sutherland
Director, Health Product Inspection and Licensing Division, Health Canada
All times are in America/Toronto.
Discussions on evolving international regulatory frameworks, modernization initiatives and their implications for Canadian regulatory affairs.
Exploration of current International Council for Harmonisation topics and developments affecting regulatory strategies.
Discussion of artificial intelligence initiatives within Health Canada and their implications for regulatory operations.
Exploration of digital standards and technologies supporting real-time exchange and review of regulatory information.
Discussion of global AI regulatory frameworks and the implications of different artificial intelligence model types for life sciences and healthcare.
Discussion of submission quality, common deficiencies and approaches to improving regulatory review outcomes.
Updates on regulatory review programs and initiatives aimed at improving submission efficiency and predictability.
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Industry and regulator perspectives on submission challenges and regulatory review processes for generic medicines.
Discussion of regulatory expectations, review challenges and submission quality for biologics and biosimilars.
Interactive discussions facilitated by Health Canada, focusing on recurring deficiencies, regulatory expectations and practical improvements to the submission lifecycle.