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Session 3, Track C: Post-marketing Surveillance: Best Practices
Session Chair(s)
Nadiya Jirova, MSc
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products
Health Canada, Canada
Myriam Salem, MSc
Pharmacovigilance Manager
Health Canada, Canada
In this session health Canada will provide practical guidance for several areas of post market surveillance. Canada Vigilance is Health Canda’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada. This session will provide practical advice on reporting Adverse Drug Reactions from various sources. A second presentation will give an overview of the process of submitting requests through Access to information and privacy (ATIP) to obtain records held by government institutions. This session will conclude with a presentation on Good Pharmacovigilance Practices (GVP) Inspection program to address common industry questions about preparing for, conducting, and observing GVP inspections.
Learning Objective : - Identify cases that must be reported to Health Canada under Food and Drug Regulations
- Understand the process of obtaining documents under Access to Information Act and prepare efficient inquiries
- Describe Inspectorate’s expectations during Health Canada GVP inspections
- Apply the acquired information to successfully prepare for GVP inspections
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