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2016-09-11T00:00:00.000Z

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Wrong Roger Goetsch?

Roger A. Goetsch

Director of Phamacovigilence

Oracle Corporation

HQ Phone: (650) 506-7000

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Oracle Corporation

500 Oracle Parkway

Redwood City, California 94065

United States

Company Description

About Oracle in IndustriesOracle industry solutions leverage the company's best-in-class portfolio of products to address complex business processes relevant to the communications industry, helping speed time to market, reduce costs, and gain a competitiv ... more

Find other employees at this company (133,227)

Background Information

Employment History

AERS Oversight and Electronic Postmarketing Coordinator

Food and Drug Administration

Director

Regulatory Affairs

Affiliations

Senior Advisor
Food and Drug Administration

Senior Advisor
Florida Department of Agriculture

Education

PharmD

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.


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.


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.

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