Monitoring Branded Label Changes Effectively to Ensure Proper Generic Label Documentation, Compliance and Safety
Inviting Heads, VPs, Directors, Managers, and Specialists of Labeling and Regulatory Affairs From Leading Pharmaceutical and Biotech Companies to Discuss Best Practices for Generic Label Documentation
(firmenpresse) - PHILADELPHIA, PA -- (Marketwired) -- 09/23/14 -- , the world''s largest event management group, will host the on December 3-4, 2014 in Philadelphia, PA. 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.
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, Managers, and Specialists of Labeling and Regulatory Affairs 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. 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.
Christine Simmon, SVP, Policy & Strategic Alliances, Candis Edwards, Senior Vice President, Clinical Regulatory Affairs, Kiran Krishnan, Vice President, US Regulatory Affairs, Ranjith Abraham, Sr. RA Labeling Specialist,
marcus evans conferences annually produce over 2,000 high quality events designed to provide key strategic business information, best practice and networking opportunities for senior industry decision-makers. Our global reach is utilized to attract over 30,000 speakers annually, ensuring niche focused subject matter presented directly by practitioners and a diversity of information to assist our clients in adopting best practice in all business disciplines.
Tyler Kelch
Marketing & PR Coordinator
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Datum: 23.09.2014 - 13:28 Uhr
Sprache: Deutsch
News-ID 1304719
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PHILADELPHIA, PA
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Biotech
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