This program aims to impart knowledge regarding best practices in Pharmacovigilance, reporting culture, regulatory aspects, signal detection, tools used in Pharmacovigilance and regulatory requirements of drug safety monitoring and translate the essence of Pharmacovigilance for the benefit of Public Health.

Learners will be encouraged to learn to understand and develop skills in the development of drug safety data during pre-clinical, clinical phases of drug development and during post approval period. Overall, this program will familiarize learners in advancing public health through safe and quality use of medicines.

This program is to enable the learners to protect public health through detection, assessment, understanding and prevention of adverse outcomes associated with use of medicines to ensure that the benefits of medicines outweigh the risks.

This course is designed to provide fundamental knowledge in Pharmacovigilance and impart the essence of the core of pharmacovigilance, that is demonstration of safety rather than the identification of risks. A learner who successfully completes this course should be able to demonstrate the following:

• Importance of drug safety monitoring
• History and development of Pharmacovigilance
• National and international scenario of Pharmacovigilance
• Dictionaries, coding, and terminologies used in Pharmacovigilance
• Detection of new adverse drug reactions and their assessment
• International standards for classification of diseases and drugs
• Adverse drug reaction reporting systems and communication in Pharmacovigilance
• Methods to generate safety data during pre-clinical, clinical and post approval phases of drugs life cycle
• Drug safety evaluation in pediatrics, geriatrics, pregnancy, and lactation
• Good Pharmacovigilance practice
• Regulatory requirements of drug safety monitoring
• Pharmacovigilance project management
• Case narratives of adverse events and their quality assessment
• Preparing for Pharmacovigilance inspections