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 18-19, 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.
Click on the registration link http://login.bio.org/?redirectKey=product&extra=1789
Enter your email address, and BIO members only password
Click ‘continue to registration’ there is no coupon code to enter
Enter payment information
Click ‘process my order’
You will need to enter your email address and password into BIO’s registration management system 'Personify'. If you cannot remember your password, you can use the 'Forgot Password' button. A link will be emailed so you may change your password.
If you know you do not have a BIO registration account, you will select 'Forgot Password' and then you will select 'Create Account'. You will need to provide your individual information and you will need to link yourself to a company. You may need to enter the same data twice, and we do apologize. After you have provided the individual and company data, an email will be sent so that you may complete your registration. YOU ARE NOT REGISTERED without following the link in your email and providing credit card payment at the conclusion of the registration process.
Hotel Room Block:
We have also reserved a limited number of rooms in a room block at the Melia Hotel in Berlin. To book a room in our block, please use the following link: http://www.idiso.com/extranet/hm/gen/meetings.melia.com/en/BIO_2013_MeliaBerlin.html. The room block closes on Monday, November 4th or when rooms run out.
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
The draft agenda can be found here.
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.