Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants

Posted 07 April 2016 By Zachary Brennan

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The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate.

The tours and program are part of efforts by CDER to train and develop its regulatory project management staff to further enhance review efficiency and quality by providing the staffers with a better understanding of the pharmaceutical industry and its operations.

The program gives FDA’s regulatory project managers the opportunity to tour pharmaceutical facilities and share information about project management procedures (not drug-specific information) with industry representatives over a two- to three-day period.

FDA said it anticipates bringing small groups (five or less) of regulatory project managers, including a senior level regulatory project manager, to observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/toxicology laboratories and regulatory affairs operations.

“Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue,” FDA says.

During the Site Tours Program, regulatory project managers will also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both CDER staff and industry. The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms and regulatory submission operations.

Novartis is the only company that has publicly expressed interest in allowing FDA staff to tour toxicology labs at its East Hanover, New Jersey campus, as well as its cell therapy manufacturing facility.

All travel expenses associated with the Site Tours Program will be the responsibility of CDER. Selection of participants will be based on firms having a favorable facility status as determined by FDA's Office of Regulatory Affairs District Offices. Firms interested in offering a site tour or learning more about the training should submit a proposed agenda to FDA, according to a federal register notice.

Pharmaceutical companies may submit proposed agendas to FDA until 11 April 2016.

Federal Register Notice

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Categories: Audit, Manufacturing, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDER

Tags: regulatory training, regulatory affairs, Novartis, FDA regulatory training

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