This course will provide a comprehensive overview of how to manage and report safety information according to the latest international guidelines. The topics include audits, expectations for risk-based inspections (RBI), compliance with drug safety regulations like product approval/licensing agreements from Europe Union countries or other regions where they exist; also providing an introduction to Product Safety Reviews – its purpose function(incorporating CIOMS III requirements) as well new changes brought about by 2nd revision ICH E2C standards that are applicable today’s industry practices making them essential skills every company needs!
Upon finishing this course, you will be able to:
- Recognize the fundamentals and intricacies of pharmacovigilance and drug safety.
- Recognize the reporting database for pharmacovigilance (e.g., Signal Detection, Risk Assessment, and Evaluation)
- Demonstrate an understanding of PV Guidelines (ICH E2C, WHO, etc.) and their practical applications in the workplace.
- Understand risk management concepts, tools, and methods for identifying and assessing risks.
- Examine signal management for causation assessment using a critical approach.
- Improve your writing skills when it comes to producing PV reports.
Who Should Attend
This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers.