This workshop is regarding the FDA and Health Canada Regulations and International Guidelines for collecting, assessing, and reporting adverse events to regulatory authorities for Pharmaceuticals, Medical Marijuana, Medical Devices, Cosmetics, and Natural health Products.
· Introduction to Drug Safety reporting as part of pharmacovigilance activities
· ICSR and sources of product safety information during the product life cycle
· FDA and Health Canada regulatory requirements for safety reporting
· Requirements for collection of safety information from FDA, Health Canada and CIOMS
· ICSR causality assessment and medical review tasks
· Requirements for processing and assessing ICSRs and case narratives
· Company Core Data Sheet (CCDS) and Company Core Safety Information (CCSI)
Who should attend:
· Staff from the regulatory authorities
· Regulatory Inspectors and auditors
· Medical writers and consultants
· Regulatory Affairs Associates and Managers
· Drug Safety Associates, Officers, and Managers
· Clinical Research Coordinators, Associates and Managers
· Personnel involved in Medical Information Department
· Principal investigators and research team in hospitals and CROs
· Company personnel initiating a Drug Safety team or having concerns regarding ADR compliance
SPEAKER: Pr. Peivand Pirouzi
Peivand holds a Ph.D in Physiology and Biophysics from School of Medicine, University of Sherbrook, and an MBA from American Business Administration Institute, and he is accredited by the Canadian Council of Pharmaceutical Education with certificates 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 100 technical and scientific reports.
|Basic Member Single Ticket:||$525.00||— Sold Out|
|Basic Member Group Tickets (5+):||$450.00||— Sold Out|
|Pro/Pro Plus Single Ticket:||$495.00||— Sold Out|
|Pro/Pro Plus Group Tickets (5+):||$420.00||— Sold Out|