| Description |
Product safety is a complex issue both for clinical trial safety and post-marketing pharmacovigilance. That is why it is important to regularly evaluate the safety of marketed medical products. This two-day workshop will address the inherent limitations of marketing and testing for risk associated with medical products, the increased dimensions of risk management to product safety as a maturing discipline, and how to refine and enhance the value of risk management applications in the name of public health.
Featured Topics
· Risk Management
· National pharmocovigilance programme: Progress, Status and Challenges
· KPO-Pharmacovigilance Model
· Human Resource Development in Pharmacovigilance
· Management of Pharmacovigilance the MNC Way
Learning Objectives:
At the conclusion of this workshop, participants should be able to:
· Explain key aspects of current global safety reporting requirements for prescription and over-the-counter drugs
· Discuss the latest regulatory frameworks of pharmacovigilance in the US, Europe, Japan and Asia-Pacific
· Explain the application of epidemiological approaches during drug safety surveillance
· Recognize new pragmatic approaches to pharmacovigilance as proposed by the CIOMS working groups
· Describe regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan
· Identify best practices for quality assurance in post-marketing pharmacovigilance and clinical safety
Professionals with experience in clinical safety and who are involved in:
· Pharmacovigilance
· Clinical research
· Risk management
· Compliance
· Medical information
· Regulatory affairs
· Academia
· Pharmacology
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