This intensive 1-day comprehensive course provides participants with a solid understanding of the Medical Device Regulations in Canada and the USA as well as the procedures for Investigational Testing involving Human Subjects. It will also give insight to the requirements for advertisement, labelling, study conduct and monitoring, reporting Adverse Events, complaint handling and how all of these apply to a quality management system.
The key points will include:
- Applications for clinical testing
- ICH-GCP and quality system requirements
- Study design
- Ethical considerations
- -Independence Ethics Committee (IEC)
- Institutional Review Board (IRB)
- Adverse Event (AE) reporting
- Audit/Inspection Procedures
- Handling of Personal Health Information
WHO SHOULD ATTEND
- Regulatory Affairs Professionals
- Quality Assurance Personnel
- Clinical Research Associates
- Drug Safety and Pharmacovigilance
- Medical Science Liaisons
- Sales and Marketing Individuals involved in KOL relationship management
SPEAKER: Peivand Pirouzi, Ph.D., MBA. CCPE
Peivand holds a Ph.D. in Physiology and Biophysics from School of Medicine, University of Sherbrook, and MBA from American Business Administration Institute, and he is accredited by the Canadian Council of Pharmaceutical Education with certifications in Evidence Based Medicine, Psychiatry, and Management.
Peivand’s industrial experience includes Wyeth/Pfizer, ApoPharma/Apotex, as well as collaborations with EliteMed and Medipure Pharmaceuticals. His government and corporate training experience covers companywide pharmaceutical and sales training on a multitude of subjects.
He has extensive pharmaceutical teaching experience to personnel ranging from Health Canada Inspectorate (in pharmacovigilance) to pharma industry organizations such as Nestle, Teva, Biopharma Services, 3M, Medipure Pharmaceuticals, and Patheon.
He has authored more than 65 scientific realizations, including 12 publications in the National Library of Canada, articles in peer-reviewed journals, oral and poster presentations, and more than 1000 technical and scientific reports.
|Student Ticket:||$250.00||— Sold Out|
|Non-Member Ticket:||$525.00||— Sold Out|
|Non-Member Group Tickets (5+):||$450.00||— Sold Out|
|Pro/Pro Plus Ticket:||$495.00||— Sold Out|
|Pro/Pro Plus Group Tickets (5+):||$420.00||— Sold Out|