Generics Labeling 2014 Conference
Building on the success of the marcus evans generic pharmaceuticals series, the Generics Labeling 2014 Conference will bring together executives charged with navigating various facets of pharmaceutical labeling and regulatory affairs to increase awareness of safety changes pertaining to the branded drug on Daily Med and the FDA Office of Generic Drugs. This forum will also address the Drug Quality and Security Act HR 3204 (DQSA) which will improve international track and trace practices, allowing increased monitoring of the product to document safety updates faster and ensure compliance on a global scale.
The U.S. Food and Drug Administration (FDA) will soon be issuing a final rule that would allow generic drug makers to follow the same process as branded drug manufacturers in updating safety information on their product labels. Given the variation between the brand and generic label, it makes it even more imperative to remain vigilant about safety updates and Reference Listed Drug (RLD) updates to ensure compliance with FDA guidelines.
Heads, Vice Presidents, Directors and Managers of Labeling and Regulatory Affairs from leading pharmaceutical companies will deliver case studies focused on integrating branded product label changes reported on FDA and Daily Med to ensure generic label compliance, while disclosing pharmacovigilance concerns to regulators to ensure safety and documentation is current in both the branded and generic products.