BIO’s Preclinical Safety Committee (BioSafe) will hold its BioSafe Europe Meeting in Berlin, Germany on November 18-19, 2013 at Bayer Pharma AG. 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.
For more information please contact Victoria Dohnal
The mission of BioSafe is to serve as a resource for BIO members and BIO staff by identifying and responding to key scientific and regulatory issues related to the preclinical safety evaluation of biopharmaceutical products.
The General Membership consists of over 30 companies who work on white papers, responses to regulatory guidance, and expert topic meetings. These companies also make up various ad hoc subcommittees including the Specialty Biologics Expert Working Group, the PK/PD Working Group, and the Comparability Task Force.
About the Meeting:
• When: November 18-29,2013
• Where: Bayer Pharma AG; Berlin, Germany
• Who: BIO members engaged in the conduct and reporting of preclinical safety evaluations for biopharmaceuticals.
Registration Information: This meeting is open to BIO member company staff engaged in the conduct and reporting of preclinical safety evaluation for biopharmaceuticals. Registration is not limited to BioSafe members, but your company must be a member of BIO.
Further details on registration and a hotel block are forthcoming.
Animal use in Biologics Development
Distribution of Biologics
Hot topics in ADC Development
Advanced Biologics – Challenges in PK and Toxicology
Use of Minipigs in Non-clinical Safety Testing with Biotherapeutics
Unexpected Toxicity of Biologics – Beyond Exaggerated Pharmacology
Non-traditional mAbs– PK and Safety Implications
BioSafe is a committee within 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.