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MedTechConf Event

CAPRA 2026 Regulatory Affairs Symposium

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

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CAPRA 2026 Regulatory Affairs Symposium

About This Event

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.

calendar_month

Date

Tuesday, Dec 1, 2026–Wednesday, Dec 2, 2026
schedule

Time

12:00 AM
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location_city

Venue

Toronto

Canada

business

Hosted By

Canadian Association of Professionals in Regulatory Affairs (CAPRA)

Speakers

  • KR

    Kelly Robinson

    Director General, Pharmaceutical Drugs Directorate, Health Canada

  • MG

    Mark Gray

    Senior Adviser, Submission Strategy, LORENZ Life Sciences Group

  • LL

    Laurent Lefebvre

location_on

Toronto, Canada | The Westin Toronto Airport, 950, Dixon Road, West Humber-Clairville, Etobicoke North, Etobicoke, Toronto, Ontario, M9W 5N4, Canada

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CAPRA 2026 Regulatory Affairs Symposium

View Event Details

Head, RA Data & Technology, Novartis

  • RF

    Ron Fitzmartin

    Principal Consultant, Decision Analytics, LLC

  • CA

    Craig Anderson

    Business Product Director, Labelling, Johnson & Johnson

  • LL

    Lorelle Leonienco

    Executive Lead, Government & Regulatory Intelligence, LORENZ Life Sciences Group

  • KY

    Khaled Yahiaoui

    Associate Director, Regulatory Operations, Merck Canada

  • TM

    Tim MacDonald

    Project Lead, Enablement of Artificial Intelligence, Health Products and Food Branch, Health Canada

  • SV

    Seema Verma-Pharasi

    Executive Director, Health Products and Food Branch, Health Canada

  • IP

    Irena Pastorekova

    Regulatory Enablement Services and Business Facilitation and Modernization Directorate, Health Canada

  • KP

    Katerina Paschakis

    Manager, Project Portfolio Management Office, Health Products and Food Branch, Health Canada

  • NM

    Nadine Mukri

    Regulatory Operations Professional

  • VY

    Veronica Yip

    Manager, Labelling Division, Pharmaceutical Drugs Directorate, Health Canada

  • AS

    Amanda Starr

    Clinical Scientific Evaluator, Metabolic and Musculoskeletal Drugs Division, Health Canada

  • MC

    Michaël Cardinal

    Co-Founder and CEO, AppGuide (formerly TherAppX)

  • CM

    Charles Mathis

    Regulatory Solutions Architect, LORENZ Life Sciences Group

  • AC

    Andrée-Anne Chevalier

    President, Vigilance Santé

  • JM

    Joe Mikhael

    Manager, Digital Regulatory Operations Section, Health Products and Food Branch, Health Canada

  • TB

    Tracy Brown

    Senior Project Manager, Business Facilitation and Modernization Directorate, Health Canada

  • MW

    Michael Wood

    Senior Regulatory Information Officer, Health Canada

  • TR

    Tanya Ramsamy

    Interim Director, Bureau of Pharmaceutical Sciences, Pharmaceutical Drugs Directorate, Health Canada

  • CG

    Christiane Grisé-Bard

    Associate Director, Bureau of Pharmaceutical Sciences, Health Canada

  • BC

    Betty Cory

    President and Co-Founder, Regxia Inc.

  • LD

    Lori deMunnik

    Vice President and Co-Founder, Regxia Inc.

  • KW

    Kristin Willemsen

    Vice President, Scientific & Regulatory Affairs, Canadian Generic Pharmaceutical Association

  • EC

    Elana Cherry

    Director, Centre for Blood, Blood Products and Biotherapeutics, Health Canada

  • AT

    Amy Tsung

    CMC Group Manager, Regulatory Affairs, GSK Canada

  • SH

    Sukhvir Hundal

    Head of Regulatory Affairs, Biocon Biologics Canada; Co-Chair, Biosimilars Canada Science Committee

  • DD

    Denise David

    Vice President, Scientific Affairs, Kye Pharmaceuticals

  • DH

    Dalia Haddad

    Senior Advisor, Health Product Compliance Directorate, Health Canada

  • RH

    Rachel Hanna

    Senior Evaluator, Biologic and Radiopharmaceutical Drugs Directorate, Health Canada

  • RM

    Robert Mitchell Baldwin

    Senior Clinical Evaluator, Clinical Evaluation Division-Oncology and Radiopharmaceuticals, Health Canada

  • MS

    Melissa Sutherland

    Director, Health Product Inspection and Licensing Division, Health Canada

  • Program

    All times are in America/Toronto.

    Day 1Tuesday, 1 December 2026

    1. Time TBA

      Regulatory Modernization and International Harmonization

      devicesIn person + Online

      Discussions on evolving international regulatory frameworks, modernization initiatives and their implications for Canadian regulatory affairs.

    2. Time TBA

      ICH Regulatory Initiatives and Emerging Regulatory Priorities

      devicesIn person + Online

      Exploration of current International Council for Harmonisation topics and developments affecting regulatory strategies.

    3. Time TBA

      Health Canada's Artificial Intelligence Journey

      devicesIn person + Online

      Discussion of artificial intelligence initiatives within Health Canada and their implications for regulatory operations.

    4. Time TBA

      FHIR, APIs and AI for Regulatory Information Exchange

      devicesIn person + Online

      Exploration of digital standards and technologies supporting real-time exchange and review of regulatory information.

    5. Time TBA

      Global AI Regulations and Regulatory Decision-Making

      devicesIn person + Online

      Discussion of global AI regulatory frameworks and the implications of different artificial intelligence model types for life sciences and healthcare.

    Day 2Wednesday, 2 December 2026

    1. Time TBA

      Building High-Quality Regulatory Submissions

      devicesIn person + Online

      Discussion of submission quality, common deficiencies and approaches to improving regulatory review outcomes.

    2. Time TBA

      Health Canada Regulatory Review Programs

      devicesIn person + Online

      Updates on regulatory review programs and initiatives aimed at improving submission efficiency and predictability.

    3. Time TBA

      Generic Medicines and Regulatory Submission Challenges

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