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BioSafe General Membership Annual Meeting
October 7-8, 2008
Genzyme Corporate Headquarters
Cambridge, MA
BIO’s Preclinical Safety Committee (BioSafe) will hold its annual general membership meeting on October 7-8, 2008 at Genzyme headquarters in Cambridge, MA. This meeting is open to BIO member company staff engaged in the conduct and reporting of preclinical safety evaluation for biopharmaceuticals. Registration is available at online.
The meeting’s goal is to provide industry experience and perspectives gained to help ensure common understanding and continued application of scientific principles with respect to key issues in preclinical safety evaluation of biopharmaceuticals. Such issues include the validation and acceptance of alternative methods, the use of non-traditional animal models, and innovations in experimental design, all aimed at improving the predictive value of preclinical studies.
The meeting includes interactive sessions on timely regulatory topics and opportunities to network.
Agenda topics include:
- Incidental Findings & Infection in Nonhuman Primates
- Agonistic Protein Products, Enabling Successful INDs
- Single Species Safety Evaluations
- Cytokine Release Assays - Current Approaches and Considerations
- ICH Updates & Regulatory Initiatives
BioSafe is a committee within the BIO’s Health Section, comprised of BIO members working to identify key scientific and regulatory issues and developments related to the preclinical safety evaluation of biopharmaceutical products and recommending appropriate science-based responses. For more information, please contact Katie McCarthy at kmccarthy@bio.org or Jennifer Martin at jmartin@bio.org.
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