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Short Course | October 11

Meeting | October 18-19

The DIA’s Canada Annual Meeting will deliver a comprehensive overview of the current biopharma and device landscape in Canada, while sharing insights into Canada’s broader role in global healthcare product development.

All participants at this event are required to be fully vaccinated. To view our vaccine policy and mask requirement, click here.

  • Event Goals and Offerings

    • Discuss policy updates and priorities shared directly from Health Canada
    • Discover international partnerships with consideration to regulatory, clinical, and safety for drugs and devices
    • Address the current issues and opportunities in Canada and beyond
    • Pharmacovigilance track added:
      • Additional insights, education and knowledge sharing to analyze relevant challenges and opportunities for professionals in Canada

      View Agenda

  • Targeted Learning Sessions

    Regulatory Track

    • Gain a clearer understanding about Health Canada’s modernization initiatives with complementary perspectives from industry on:
      • Regulatory Review of Drugs and Devices (R2D2)
      • Real-World Data and Real-World Evidence
      • Innovation and Collaboration in Oncology
      • Overview of Health Canada’s “Agile Licensing for Drugs”
      • Overview of Health Canada’s “Agile Licensing for Medical Devices”

    Clinical Track

    • Focused track on clinical research development and operations for industry
    • Includes Health Canada’s approaches to the modernization of clinical trial regulations, patient contribution to resource development, and its potential to transform the way we conduct clinical research
    • Gain insights from industry, regulators, and patients on clinical trial design and conduct
    • Review real-world insights into the benefits and challenges of incorporating real-world data/evidence into decisions about clinical trials
    • Gain insights on the importance of the transparency of clinical trial information and measures

    Pharmacovigilance Track

    • New to our program this year, this track will provide a comprehensive overview of Canada’s regulatory environment in the field of clinical safety and pharmacovigilance for biopharmaceutical products and medical devices
    • Enjoy an overview of key considerations for successful risk minimization
    • Discuss good Pharmacovigilance Practices (GVP) Inspections, the impact of Vanessa’s Law, and the use of AI

  • Learning Objectives

    At the conclusion of this activity, participants should be able to:

    • Describe Health Canada’s Regulatory Review of Drugs and Devices (R2D2), the current status and progress of initiatives achieved, and how they have led to Health Canada’s Regulatory Modernization Framework
    • Understand Health Canada’s plan for regulatory modernization for drugs including the use of Terms and Conditions, Risk Management Plans and Rolling Reviews
    • Describe the transparency measures that Health Canada is contemplating to guide and encourage sponsors for clinical trial registration
    • Describe adaptive designs in clinical trials and the role that technology can play on remote monitoring, data collection and consent
    • Describe key elements of Health Canada’s Agile Licensing for Medical Devices, the specific attributes of Health Canada’s regulatory innovation plan, and impact on local and global regulatory strategies
    • Explain how RWD and RWE can be leveraged to support regulatory decision making
    • Discuss what is expected during Health Canada‘s good vigilance practices (GVP) inspections and proactive compliance monitoring projects (CMPs), including current and future approaches for virtual inspections
    • Understand the use and future of artificial intelligence in pharmacovigilance and the expectations from Health Canada
    • Describe the FDA Oncology Center of Excellence’s mission, vision, and initiatives, and the principal benefits and challenges of Project Orbis
    • Explain Health Canada’s expectation regarding the implementation of Vanessa’s Law and the challenges faced by industry due to its implementation
    • Recognize the importance of incorporating the patient voice and experience throughout the drug development life cycle
  • Meeting Designed For

    • Pharmacovigilance
    • Clinical Research, Management, Safety & Ops
    • Medical Affairs and Communication
    • Quality Assurance Control
    • Public/Corporate Policy & Regulatory Affairs
    • R&D and Risk Management
    • Project Management & eSubmissions
    • Real-World Evidence and Statistics
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Program Committee

  • Maria  Anillo, MSc
    Maria Anillo, MSc Regulatory Affairs Project Manager
    AstraZeneca Canada Inc., Canada
  • Marcia  Bailey, BSN, MHS, RN
    Marcia Bailey, BSN, MHS, RN Safety Evaluation & Risk Management Scientific Director
    GSK, Canada
  • Marilyne  Chamoun, MSc
    Marilyne Chamoun, MSc Senior Scientific Evaluator, Marketed Pharmaceuticals Bureau
    Health Canada, Canada
  • Mandy  Collier
    Mandy Collier Director, Health Products and Food Branch
    Health Canada, Canada
  • Lucye  Galand, DVM, MBA, MSc
    Lucye Galand, DVM, MBA, MSc Acting Director, BGIVD, Therapeutic Products Directorate, HPFB
    Health Canada, Canada
  • Lorella  Garofalo, PhD
    Lorella Garofalo, PhD Head of Regulatory Sciences
    Pfizer Canada, Canada
  • Agnes  Jankowicz, MS
    Agnes Jankowicz, MS Vice President, Pharmacovigilance
    Veristat, Canada
  • Oxana  Iliach, PhD
    Oxana Iliach, PhD Sr. Director, Regulatory Strategy
    Certara, Canada
  • Yatika  Kohli, PhD, MBA
    Yatika Kohli, PhD, MBA Chief Regulatory and Strategy Officer
    NoNO Inc, Canada
  • Judith  Mergl, MSc
    Judith Mergl, MSc Director, Regulatory Affairs and Operational Services
    AbbVie Corporation, Canada
  • Myriam  Salem, MSc
    Myriam Salem, MSc Senior Corporate Regulatory and Enforcement Advisor
    Health Canada, Canada
  • Marcia  Sam
    Marcia Sam Regulatory Affairs Strategy and Policy Manager
    Hoffmann-La Roche Canada Limited, Canada
  • Vanessa  Zapata
    Vanessa Zapata Associate Director, Regional Pharmacovigilance Officer
    Merck Canada Inc., Canada
  • Representative Invited
    Representative Invited DIA, United States
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