Drug lifecycle safety management involves the ongoing monitoring of the safety and efficacy of drugs throughout their lifecycle, from preclinical development through post-marketing surveillance. Pharmacovigilance compliance is the process of ensuring that all pharmacovigilance activities, including adverse event reporting and risk management, comply with applicable regulations and guidelines.
Pharmacovigilance regulations require that pharmaceutical companies collect, analyze, and report adverse events that occur during clinical trials and post-marketing surveillance. These reports are used to monitor the safety of drugs and to make informed decisions about their continued use.
Drug safety reporting is a complex process that involves the collection and analysis of data, the determination of causality, and the reporting of adverse events to regulatory authorities. Failure to comply with pharmacovigilance regulations can result in significant penalties and can damage the reputation of the company.
The course provides the students with knowledge of assessment of adverse events and drug safety reporting in clinical trials and in the pre-and post-approval periods. Students will have a practical understanding of Pharmacovigilance processes and documentation in all stages of the drug’s lifecycle as well as drug safety reporting during clinical development and post-clinical stage.
Drug Product Lifecycle: Pharmacovigilance Focus
Drug Safety Reporting Processes in Clinical Trials
Post-Marketing Adverse Event Reporting: Sources, Processes, and Requirements
Expedited Reporting Requirements
US Pharmacovigilance Requirements for all Stages of Drug Product Lifecycle
Adverse Drug Reaction report (FDA3500A)
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