Health Canada Regulatory and Clinical Modernization Initiatives Virtual Workshops

Details Download to Calendar Speakers / Panelists Downloads Sponsors

May 18, 2021, and May 20, 2021

Virtual Workshops

Registration is now closed.

Thank you for accepting the Microsoft team invitation to join the upcoming workshop. I have sent two invites, one for Session one, May 18, 2021, and the second for Session two, May 20, 2021.
If you have not yet accepted the invitation, please accept the invite so that you can join without any issues. I have double-checked my invite list and everyone who is registered has been sent the invite. Please check your Junk folder/spam folder if you have not received my invite.
I will be busy hosting the event on both days and might not be able to respond to your emails immediately.
Thank you.
Hareet Aujla

The calendar invitations with the link to join the Symposium on each day will be sent to registrants via the email address in their registration.

If you have not received the invitation by noon on May 17^th, please contact the CAPRA administrator (administrator@capra.ca).

These two virtual interactive workshops with Health Canada officials will provide attendees with information on regulatory modernization initiatives being undertaken within the Department. The first session will focus on Regulatory Innovation Agenda, Regulatory Modernization in Compliance and Enforcement, and Advanced Therapeutic Products, while the second session will focus on Clinical Trial Modernization initiatives. Attendees will have the opportunity to raise questions and participate in round table discussions with Health Canada officials on the modernization initiatives.

These regulatory initiatives were introduced by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap.

This event will be of interest to:

Regulatory Affairs professionals from NHP, medical devices, pharmaceuticals/biologics as well as veterinary drugs
Clinical Research
Contract Research Organizations
Clinical Data Management/Pharmacovigilance
Research and Development

Microsoft Teams will be used as the meeting platform.

Event Registration Form: Please add your First name, Last name and the Email address that you will use to join the day of the workshop.
Be sure to check system requirements to avoid any connection issues the day of the event.
In case of unexpected interruptions such as a power outage please log back, and the workshop will restart from where it was disconnected.

Click here for the brochure.

Click here to learn about sponsorship opportunities.

Speakers / Panelists

Sally Prawdzik

Senior Policy Advisor for Regulatory Innovation in Health Canada’s Health Products and Food Branch
Health Canada
Sally Prawdzik

Senior Policy Advisor for Regulatory Innovation in Health Canada’s Health Products and Food Branch
Health Canada

Sally is a Senior Policy Advisor for Regulatory Innovation in Health Canada’s Health Products and Food Branch, supporting the modernization of Canada’s drug and device regulations. Sally provides strategic advice in the implementation of Health Canada's Regulatory Innovation Plan, including stakeholder engagement plans and supporting the implementation of the new pathway for Advanced Therapeutic Products. Prior to joining Health Canada in 2019, Sally worked in a number of senior regulatory and quality positions at Johnson & Johnson, as well as in a start-up pharmaceutical environment.
Catherine Hudon

Director, Compliance Policy and Regulatory Affairs Health Canada
Health Canada
Catherine Hudon

Director, Compliance Policy and Regulatory Affairs Health Canada
Health Canada

Catherine is the Director of Compliance Policy and Regulatory Affairs in Health Canada’s Regulatory Operations and Enforcement Branch. In this role, Catherine leads a broad range of compliance and enforcement policy initiatives. Most recently, this has included the interim order on exceptional importation in response to the COVID-19 pandemic. Catherine has over 15 years of policy experience in the Government of Canada, having worked in departments such as Indigenous and Northern Affairs, Economic and Social Development, and the Treasury Board Secretariat.
Kenneth Joly

Policy Analyst, Office of Policy and International Collaboration, Biologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch
Health Canada
Kenneth Joly

Policy Analyst, Office of Policy and International Collaboration, Biologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch
Health Canada

Kenneth Joly is a Senior Policy Analyst in the Office of Policy and International Collaboration at the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Canada, and he has worked at BRDD since 2008. Ken is one of the policy leads on implementing the Advanced Therapeutic Products (ATP) Pathway. Before the introduction of the ATP pathway, Ken worked on policy files in various areas, such as radiopharmaceuticals, items that challenged the Food and Drug Regulations (such as Fecal Microbiota Therapy and medicinal maggots and leech), and stakeholder engagement, including coordinating BRDD’s Bilateral Meeting Program. Ken has a Bachelor of Social Sciences from the University of Ottawa and a Master of Science in Political Science from the University of Nebraska at Omaha.
Dr. Daniel Keene

Associate Director, Office of Clinical Trials, Therapeutic Products Directorate, Health Products and Food Branch
Health Canada
Dr. Daniel Keene

Associate Director, Office of Clinical Trials, Therapeutic Products Directorate, Health Products and Food Branch
Health Canada

After obtaining his medical degree from the University of Saskatchewan, he completed his post-graduate medical training in pediatrics at the Hospital for Sick Children in Toronto, and neurology at the Montreal Neurological Institute. He is a fellow of the Royal College of Physicians and Surgeons of Canada with speciality certification in both pediatrics and neurology. In addition, he has obtained a Master of Arts in Public Policy from Carleton University and a Graduate Certificate in Academic Excellence in Epidemiology form the School of Public Health, University of Michigan.

Prior to coming to Health Canada, he was an active member of the Medical Faculty at the University Ottawa in the Departments of Pediatrics and Medicine, and Senior Clinical Investigator at the Children’s Hospital of Eastern Ontario. He has authored over a 100-peer reviewed scientific articles on variety of topics including identification of pediatric neurological disorders, neuro-oncology, epidemiology and health policy; as well as contributing to several sentinel medical textbooks in these areas.
Marie-Pierre Desrosiers

Scientific Evaluator, Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance, Medical Devices Directorate, Health Products and Food Branch
Health Canada
Marie-Pierre Desrosiers

Scientific Evaluator, Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance, Medical Devices Directorate, Health Products and Food Branch
Health Canada

Mrs. Desrosiers holds a Bachelor degree in Biopharmaceutical Sciences from the University of Ottawa and a Master degree in Human Genetics from Mcgill University. She has many years of experience in research including clinical trials within the hospital setting and the private industry. She is currently working as a Scientific Evaluator in the Medical Devices Directorate at Health Canada. Part of her role is to review applications for Investigational Testing Authorizations (ITA), to verify and ensure that investigational medical devices adhere to the safety, effectiveness and quality requirements outlined in the Medical Devices Regulations.
Lisa Chartrand

Director, Regulatory Strategy and Policy
Roche Canada
Lisa Chartrand

Director, Regulatory Strategy and Policy
Roche Canada

Lisa Chartrand began her career in the industry with Apotex as a quality assurance chemist and found her passion in Regulatory Affairs when she joined EMD Serono in 1999. At Roche Canada since 2003, she has enjoyed many growth opportunities in Regulatory Affairs and Medical Affairs and was appointed Director, Regulatory Affairs in 2014. Lisa is co-chair and an active member of Innovative Medicines Canada's Regulatory Operations Team and a member of BioteCanada's Biologics Regulatory Affairs Group (BRAG). Lisa earned her Bachelors of Science in Microbiology and Immunology from McGill University in Montreal, Quebec and holds a certificate from TIPT in Quality Assurance.