Pharmacovigilance risk management is the process of identifying, evaluating, and minimizing the risks associated with the use of pharmaceutical products. This process is an essential part of drug development and post-marketing surveillance, and it helps to ensure that patients receive safe and effective medications.
The pharmacovigilance risk management process involves several steps such as; risk identification, risk assessment, risk minimization, and risk communication.
Pharmacovigilance risk management is an ongoing process that continues throughout the drug’s lifecycle. It is essential for ensuring patient safety and regulatory compliance, and it helps to improve the overall quality of pharmaceutical products.
The course provides the students with a solid understanding of pharmacovigilance and its regulation as well as AE/ADR classification, assessment, and reporting standards.
Learning Points:
- Introduction to Pharmacovigilance and Risk Management
- Risk Management and REMS
- Reporting Principles
- Pre-Marketing Reporting
- Post-Marketing Reporting