Canada Annual Meeting

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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 • Senior Associate, Established Products and Regulatory Operations
Boehringer Ingelheim, Canada
Marcia Bailey, BSN, MHS, RN • Associate Director, Pharmacovigilance Scientist
Sierra Oncology , 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 Affairs
Pfizer Canada, Canada
Agnes Jankowicz • Vice President, Pharmacovigilance
Veristat, Canada
Oxana Iliach, PhD • Sr. Director, Regulatory Strategy
Certara Synchrogenix, Canada
Yatika Kohli, PhD, MBA • Executive Director - Global Regulatory Affairs
NoNO Inc, Canada
Judith Mergl, MSc • Director, Regulatory Affairs and Operational Services
AbbVie, Canada
Myriam Salem, MSc • Senior Corporate Regulatory and Enforcement Advisor
Health Canada, Canada
Marcia Sam • Regulatory Affairs Strategy and Policy Manager
Hoffmann-La Roche Limited, Canada
Vanessa Zapata • Associate Director, Regional Pharmacovigilance Officer
Merck Canada Inc., Canada
Representative Invited • DIA, United States