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Article: Research And Markets: Lack Of Compliance With Good Clinical Practice In Sponsoring Or Performing Clinical Studies Will Result In Regulatory Sanctions And Refusal Of Approvals.
- Article from:
- Business Wire
- Article date:
- November 16, 2004
CopyrightCOPYRIGHT 2004 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c9155) has announced the addition of A Guide to Good Clinical Practice to their offering
This Guide contains the most recent versions of the regulations issued by the USA, Canada, the European Union, Japan, and the Consolidated Guidelines of the International Conference of Harmonization. Lack of compliance with GCP in sponsoring or performing clinical studies will result in regulatory sanctions and refusal of approvals, which will adversely affect a company's plans to launch a new drug product, device, or diagnostic. Regulations state that it is the responsibility of the company, ...