Canada Annual Meeting

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Overview

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:
Targeted Learning Sessions

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