Webinar: Health Canada GMP Inspections & Clinical Trials during COVID-19
CAPRA is pleased to host a special COVID-19 related Webinar by Health Canada. Topics that will be addressed include:
1. Assessment of GMP compliance/remote GMP Inspections during the COVID-19 pandemic.
2. Management of Clinical Trials during the COVID-19 pandemic.
| ITEMS | Agenda | PRESENTOR |
| Opening remarks | Dr. John Patrick Stewart, Director General Therapeutic Products Directorate, Health Products and Food Branch | |
| GMP |
Remote GMP inspections and how GMP compliance status will be addressed. If this situation continues for an extensive period of time what will be the impact/interface with drug (pharmaceuticals and biologics) submissions under review and impact in terms of ability to file where foreign site status may be expired. Questions and answers |
Kim Godard, Director
|
| Clinical Trials |
Managing clinical trials during the COVID pandemic Questions and answers |
Dr. Daniel Keene, Senior Medical Officer and Manager, Office of Clinical Trials for Biological Agents, Biologics and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch |
Registrants will be sent an automated email with a link to register for the webinar once the online registration is complete.
Please add your First name, Last name and the Email address that you will use to log in the day of the webinar.
Registrants may be substituted, but no refunds will be issued after the deadline.
Speakers / Panelists
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Dr. J. Patrick Stewart
Director General of the Therapeutic Products Directorate in the Health Products and Food Branch (HPFB)
Dr. J. Patrick Stewart
Director General of the Therapeutic Products Directorate in the Health Products and Food Branch (HPFB)
Health Canada
Dr. J. Patrick Stewart is the Director General of the Therapeutic Products Directorate in the Health Products and Food Branch (HPFB) of Health Canada. He is responsible for overseeing
the review and approval of drug and medical device submissions seeking authorization to be sold on the Canadian market or in the context of clinical trials, as well as managing the strategic vision, focus and priorities of the directorate and alignment with that of the Government of Canada.
Prior to this role Dr. Stewart was the Director General of the Marketed Health Products Directorate in the HPFB for 2.5 years where he oversaw the vigilance of marketed health products in Canada, including ensuring that Canadians and health professionals are informed of important issues impacting the safety and effectiveness of health products.
Dr. Stewart holds a Bachelor’s and Master’s degree in science as well as a Medical Doctor degree from McMaster University. In addition, he holds a CCFP Emergency Medicine certification. Over the course of his career, he worked for over 20 years as full-time emergency physician. In a former role as an Assistant Professor with the Faculty of Medicine at the University of Ottawa, he was responsible for coordinating undergraduate medical student education in the Emergency Departments in Ottawa and was actively involved in the Department’s research program.
Dr. Stewart joined Health Canada in August of 2005 and since then has filled several roles in the Therapeutic Products Directorate. -
Kim Godard
Director, Health Product Inspection and Licensing Division (HPIL) Health Product Compliance Directorate Regulatory Operations and Enforcement Branch
Kim Godard
Director, Health Product Inspection and Licensing Division (HPIL) Health Product Compliance Directorate Regulatory Operations and Enforcement Branch
Health Canada
In February 2020, Kim Godard joined the Regulatory Operations and Enforcement Branch as the Director of the Health Product Inspection and Licensing Division which is the area responsible for drug establishing licensing, Good Manufacturing Practices (GMP) inspections as well as international affairs/strategic partnerships.
Before joining this program, Kim held various roles within the Health Portfolio including that of Director of the Workplace Hazardous Materials Bureau, Associate Director of the inspection program for pharmaceuticals, Manager and Senior Advisor in the area of Tobacco Control and as Acting Director of the Natural Health Product Licensing area. Kim’s academic background is in Biochemistry and Molecular Biology. -
Dr. Daniel Keene
Senior Medical Officer and Manager, Office of Clinical Trials for Biological Agents, Biologics and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch
Dr. Daniel Keene
Senior Medical Officer and Manager, Office of Clinical Trials for Biological Agents, Biologics and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch
Health Canada
Dr. Daniel Keene is the senior medical officer and manager of the Office of Clinical Trials for biological agents within Biologics and Radiopharmaceutical Drugs Directorate of 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.
Registration is now closed