Adverse Drug Event Monitoring and Reporting
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
This course is available as a client site course. Please click here for more information.
Who Should Attend
Post for this section not available now
Description
Product safety in the pharmaceutical industry is a dynamic, constantly-changing process. Individuals within a pharmaceutical company responsible for the monitoring and reporting of safety information must be aware of the issues associated with the compliant operation of a drug safety unit. These issues include: differences in premarketing and postmarketing safety data; how safety data is presented to regulatory agencies, health professionals, and consumers; why coding of safety information is necessary; how to comply with ISO requirements and regulatory audits; the issues associated with managing a safety organization; the concept and practice of risk management; and how pharmacoepidemiology can improve the product safety profile of a product before and after marketing. This course will cover these issues and provide a forum for the exchange of information between faculty and attendees.