Description
This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company`s pharmacovigilance operations to applicable best practices.
The course will cover all aspects of drug safety and pharmacovigilance compliance including the collection, assessment and reporting of adverse event cases, the analysis of cases to detect signals, the management of signals and safety concerns, and the development, execution and monitoring of risk management plans. Why should you attend: During high profile drug withdrawals of the past, most of the focus of the press and legal community was on the actual adverse event and the people who were injured. Today the attention seems to be on the documentation of how and when companies learned of the increased frequency of adverse events and what they did about it.
Meanwhile, international regulatory guidances on drug safety monitoring are increasing. With ICH E2E and E2C, CIOMS VI and VII, and the FDA Amendment Act, companies may need to audit their pre-marketing and post-marketing safety monitoring practices to ensure they are following Good Pharmacovigilance Practices.
