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Overview

Meeting

October 18 - 19, 2022

All participants at in-person DIA Meetings, Workshops, Forums and Conferences, are required to be fully vaccinated. Please click here for more information regarding our vaccine policy and mask requirement.

Registration will close one week prior to the conference to allow time to process all registration forms and verify vaccination status. No on-site registrations will be accepted.

The DIA 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. From policy updates and priorities shared directly from Health Canada, to sessions on international work sharing and partnerships, to key regulatory, clinical, and safety considerations for drugs and devices, you will have the exclusive opportunity to address the current issues and opportunities in Canada and across the globe. This meeting presents three tracks: Regulatory, Clinical, and Pharmacovigilance. Our new pharmacovigilance track, previously its own meeting, broadens the scope of this meeting and will provide additional insights, education and knowledge sharing for our attendees to discuss and analyze the relevant challenges and opportunities for professionals working in the field in Canada.

As we work on the 2022 agenda, please take a moment to review the 2021 Program.


Social distancing measures may be in place at the time of the event. Therefore, we encourage you to register and make your housing arrangements early due to potential limited capacity. Don’t miss out on your chance to meet live again with your friends and colleagues!

Who should attend?

Professionals in pharmaceutical and device industries, regulatory agencies, and academia involved in:
  • Clinical Data Management/eClinical
  • Clinical Operations
  • Comparative Effectiveness/Health Technology Assessment
  • Clinical Safety/Pharmacovigilance
  • Clinical Research
  • Document Management/eSubmissions
  • Global Submission/Project Management
  • Medical Information, Medical Communications, and Medical Affairs
  • Outsourcing
  • Pharmacoepidemiology
  • Project Management
  • Public Policy/Law/Corporate Compliance
  • Quality Assurance Control
  • Real-World Data
  • Real-World Evidence
  • Regulatory Affairs and Operations
  • Regulatory Science
  • Research and Development
  • Risk Management
  • Statistics

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 progressof 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

Program Committee

  • Maria  Anillo, MSc
    Maria Anillo, MSc Senior Associate, Established Products and Regulatory Operations
    Boehringer Ingelheim, Canada
  • Marcia  Bailey, BSN, MHS, RN
    Marcia Bailey, BSN, MHS, RN Associate Director, Pharmacovigilance Scientist
    Sierra Oncology , 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 Affairs
    Pfizer Canada, Canada
  • Agnes  Jankowicz
    Agnes Jankowicz Vice President, Pharmacovigilance
    Veristat, Canada
  • Oxana  Iliach, PhD
    Oxana Iliach, PhD Sr. Director, Regulatory Strategy
    Certara Synchrogenix, Canada
  • Yatika  Kohli, PhD, MBA
    Yatika Kohli, PhD, MBA Executive Director - Global Regulatory Affairs
    NoNO Inc, Canada
  • Judith  Mergl, MSc
    Judith Mergl, MSc Director, Regulatory Affairs and Operational Services
    AbbVie, 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 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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