Drug Safety and Pharmacovigilance Certificate

The Drug Safety and Pharmacovigilance Certificate Program is designed to provide an introductory and advanced knowledge and skills of Pharmacovigilance, a critical component of drug development and regulation, playing a vital role in ensuring that drugs are safe and effective for use by patients. The course provides the basics of pharmacovigilance regulations and pharmacovigilance processes, and documentation. It also discusses the fundamentals of AE/ADR classification, assessment, and reporting standards.

The program focuses on topics delivered through five modules: 

• Clinical Pharmacology and Clinical Safety Assessment
• Legislations, Ethics and Good Pharmacovigilance Practices (GVP)
• Introduction to Pharmacovigilance Activities and Pharmacoepidemiological Studies
• Drug Lifecycle Safety Management and Pharmacovigilance Compliance
• GCP and GVP Inspections and Audits

A well-trained and knowledgeable Drug Safety and Pharmacovigilance professional plays a vital role in protecting the study participant and the general population for marketed drugs and in helping to reduce the time between drug development and marketing approval.