DRUG COMPANIES SOLICITED TO HELP TRAIN GOVERNMENT PROJECT MANAGERS

The FDA is calling on the pharmaceutical industry to help its regulatory project managers gain a greater understanding of the drug manufacturing process as part of its ongoing effort to bridge the information gap between industry and the agency.

In a notice published in the Nov. 28 Federal Register, the FDA announced the continuation of CDER's Regulatory Project Management Site Tours and Regulatory Interactions Program, a training and development program for the agency's regulatory staff. Participating drug companies let regulatory project managers tour their facilities to see firsthand how drugs are produced. The goal, according to CDER, is to provide regulatory project managers the opportunity to witness the drug development process and also to present a platform for sharing project management information with industry representatives.

During a two- to three-day period, small groups of regulatory project managers, along with a senior level supervisor, learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms and regulatory submissions operations.

Interested companies should submit their proposed agendas to CDER no later than Jan. 27, 2007. The notice can be seen at a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-20041.pdf (http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-20041.pdf).