BioPharm International


FDA Continues Site Tours Program

February 17, 2016
BioPharm International Editors

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

On Feb. 9, 2016, FDA’s Center for Drug Evaluation and Research (CDER) announced the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program, also known as the Site Tours Program. The program is part of CDER’s training and development programs designed to promote high performance and enhance review efficiency by providing firsthand exposure to the industry’s drug development processes.

The Site Tours Program allows small groups of regulatory project managers to observe the manufacturing operations of participating pharmaceutical companies in order to gain more understanding of manufacturing processes. The regulatory project managers also participate in workshops with industry counterparts to learn about a team approach to drug development.

Pharmaceutical companies interested in participating in the program should submit proposed agendas to FDA by April 11, 2016.

Source: FDA