“Best Practices” for post-market surveillance & regulatory reporting of dietary supplement and OTC drug adverse events.
Although “Best Practice” AE Processes can be fairly straightforward, there are a variety of challenges a manufacturer must overcome when implementing an AE system. These can include designing a database, developing SOP’s for managing, documenting, analyzing and reporting indicated events, and overcoming internal political obstacles in identifying and securing resources. Lastly, is meeting the letter of the law all that needs to be done? How can a company that meets all regulatory requirements still be at risk!
Join Dr. Richard Kingston, President of Regulatory and Scientific Affairs at SafetyCall International, for this free, one hour webinar. Register now to learn your reporting obligations and how the market space is continually changing when it comes to AE compliance.