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2010-10-19T00:00:00.000Z

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Background Information

Employment History

Director of Regulatory Affairs
Food and Drug Administration

Director Regulatory
Food and Drug Administration

Web References (3 Total References)


"We have had some problems with ...

www.chimediagroup.com [cached]

"We have had some problems with the Gateway," Roger Goetsch, FDA director of regulatory affairs, said at the DIA meeting. "We're still dealing with paper. Our regulation says: paper."

The FDA also declined to explain the pace of modernization of its safety systems, or its plans to encourage the industry to supply more reports electronically. At DIA, however, Goetsch said, "We know [the amount of reports] is going to go up 10 to 15 percent a year. We can't hand-type these in.


Safety Last? - Archive

www.bio-itworld.com [cached]

"We have had some problems with the Gateway," Roger Goetsch, FDA director of regulatory affairs, said at the DIA meeting."We're still dealing with paper.Our regulation says: paper."

The FDA also declined to explain the pace of modernization of its safety systems, or its plans to encourage the industry to supply more reports electronically.At DIA, however, Goetsch said, "We know [the amount of reports] is going to go up 10 to 15 percent a year.We can't hand-type these in.


DIA

www.diahome.org [cached]

Sabine Brosch, MSc, PhD, Deputy Head of Sector, Pharmacovigilance, European Medicines Agency, UK; Roger A. Goetsch, PharmD, Director, Regulatory Affairs, Office of Drug Safety, CDER, FDA; William W. Gregory, PhD, Director, Safety and Risk Management, Pfizer, Inc.; and Kostas Kidos, MSc, Senior Director, Regulatory Information Services, Merck & Co.

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