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?
- 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
Contact us
Registration Questions?
Additional Information
Live Meeting PoliciesCanada Annual Meeting Resource Kit