Pharmacovigilance
The Pharmacovigilance course is designed to train participants in the monitoring and assessment of pharmaceutical product safety.
The program covers adverse drug reactions, risk management, and the regulatory aspects of drug safety reporting based on European GVP.
Students will acquire the skills needed for adverse event reporting, signal detection, and risk assessment, ensuring they can effectively contribute to the safety and efficacy of pharmaceutical products in compliance with regulatory standards.
This course is designed for professionals seeking in-depth knowledge of pharmacovigilance practices, adverse drug reactions, and safety reporting. Participants will gain expertise in risk assessment, regulatory compliance, and effective communication strategies related to medicines safety.
This course provides a comprehensive foundation in pharmacovigilance and drug safety, covering essential concepts such as ADR classification, signal detection, safety monitoring, benefit-risk assessment, and adverse drug event reporting. Participants will learn to prepare key regulatory reports like DSURs and PSURs, ensuring compliance with global standards.
This course offers an in-depth exploration of drug safety and pharmacovigilance, focusing on risk management, compliance, regulatory communication, and the unique aspects of the Indian Pharmacovigilance Program. Participants will gain expertise in signal detection, audits, and international PV regulations, preparing them for key roles in ensuring drug safety and compliance.
This course provides an in-depth exploration of pharmacovigilance, focusing on adverse drug reactions, safety reporting, and advanced MedDRA coding techniques. Participants will gain expertise in data analysis, risk management, and standardized query building, ensuring comprehensive drug safety and regulatory compliance.