Healthcare professionals, toxicologists and other scientists at SafetyCall International have been managing product related adverse events on behalf of manufacturers for decades. During this time SafetyCall has managed more than 3,000,000 incidents and helped manufacturers with early detection of safety issues and implement strategies to manage and mitigate adverse events. SafetyCall’s experience and methodology in this important area has recently …
Webinar: Best Practices for Adverse Event Management and Reporting
On August 9, 2012, Rick Kingston, President, Regulatory and Scientific Affairs at SafetyCall International, will be presenting as a part of the SOCAP International Webinar Series. His presentation is titled, “Best Practices for Adverse Event Management and Reporting” and will cover:
- Potential implications of pending and newly-implemented changes to regulations over adverse event reporting requirements for consumer products.
- FDA’s new
Is your Company Compliant? Learn More at our “Best Practices” Webinar
“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 …