Certification Course in PHARMACOVIGILANCE

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products.

Course Topics:

• Pharmacovigilance in Clinical Research
• Principle of Pharmacovigilance
• Signal Detection and its management
• Principle of aggregate safety report management
• Pharmacovigilance methods
• Global Pharmacovigilance overview
• Medical coding
• Individual case safety report – I, II, III overview
• Safety Database
• Risk Management and Risk Benefit Assessment