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		Introduction FDA EMEA ICH

David A. Dodd to Lead BioReliance Corporation
David A. Dodd has joined BioReliance as the Company's President, Chief Executive Officer and Chairman of the Board, effective December 3, 2007. From 2000 through 2006, Mr. Dodd served as President and CEO of Serologicals Corporation, a publicly traded company that was sold to Millipore Corporation in 2006 for $1.4 billion. Prior to that, from 1995 Mr. Dodd was President and CEO of Solvay Pharmaceuticals, Inc.
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David L. Bellitt joins Bioreliance David L. Bellitt has been named Vice President of Global Commercial Operations, Biologics. Mr. Bellitt will be responsible for all global commercialization activities, including sales, marketing and customer service. He will also serve as a member of the Corporate Operating Committee.
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BioReliance Corporation Launches iNet™ for Online Results Tracking of Biological Safety Tests BioReliance is pleased to announce to US customers the release of iNet, a proprietary information technology system for submitting and tracking test article details via a controlled and secure Internet access from any location worldwide. Now you can view the status of current and past studies, keep informed of when testing will be completed, download reports, and allow your colleagues to view the status of your tests.
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This page provides access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organisation.

The International Committee for Harmonisation (ICH)

These guidelines have been prepared through close co-operation between the European Union, Japan and the United States of America.

DOCUMENT TITLE* *Note: these links take you directly to the documents on the ICH or other authorities' web site. Please let us (info@bioreliance.com) know if you have problems accessing them.	DOCUMENT TYPE	DATE POSTED
Q7A; Good Manufacturing Practices for Active Pharmaceutical Ingredients.*	Note for Guidance	2000
Q6B; Specifications, Test and procedures for Biotechnological/Biological Products*	Note for Guidance	1999
Q5D; Derivation and Characterization of Cell substrates Used for Production of Biotechnological/Biological Products*	Note for Guidance	1997
S6; Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals*	Note for Guidance	1997
E8; General Considerations for Clinical Trials*	Note for Guidance	1997
S2B; Genotoxicity - A Standard Battery for Genotoxicity Testing of Pharmaceuticals*	Note for Guidance	1997
Q5A; Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin*	Note for Guidance	1997
Q5B; Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for the Production of r-DNA Derived Protein Products*	Note for Guidance	1996
Q5C; Quality of Biotechnological Products:Stability Testing of Biotechnological/Biological Products *	Note for Guidance	1996
E6; Guideline for Good Clinical Practice *	Note for Guidance	1996

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