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