SOURCE: IBC Life Sciences

August 08, 2005 15:03 ET

Evolving Regulatory Policies Challenge Biopharmaceuticals

U.S. Food and Drug Administration Explores Latest Regulatory Changes at IBC Conferences

WESTBOROUGH, MA -- (MARKET WIRE) -- August 8, 2005 -- Evolving regulatory policies for biopharmaceutical products coupled with emerging analytical technologies for characterized biologics continue to push industry professionals to keep products on the fast track.

IBC Life Sciences combines its 8th Annual Well Characterized Biologicals and 7th International Viral Safety conferences to bring together scientists and regulatory professionals to discuss strategies and approaches for overcoming the technical challenges and regulatory hurdles surrounding the characterization and validation of biological products. The co-located conferences are set for November 14-15, 2005 at the Hyatt Regency in Reston, Virginia.

These conferences provide case studies, presentations by U.S. Food and Drug Administration regulators and the latest technological developments by industry experts. Presentations examine proven characterization and validation techniques to help achieve the fastest possible regulatory approval.

Feature presentations include:

--  Emily Shacter, Ph.D., Center for Drug Evaluation and Research, U.S.
    Food and Drug Administration presents "Know Your Product, Control Your
    Process: What Does That Mean?"
--  Roman T. Drews, Ph.D., Center for Biologics Evaluation and Research,
    U.S. Food and Drug Administration provides CBER perspectives on viral
    safety: Well characterized biologicals
--  Thomas R. Kreil, Ph.D., Baxter BioScience discusses robustness of
    virus inactivation and industry wide data collection for solvent-detergent
    (S/D) treatment
--  Nadine M. Ritter, Ph.D., Biologics Consulting Group, LLC explores
    considerations for HCP assays from product development through product
--  Dieter Schmalzing, Ph.D., addresses Genentech's lifecycle approach to
    setting release criteria and shelf-life specifications
--  Ned Mozier, Ph.D., looks at Pfizer's comprehensive host cell protein
    analysis staged through development

Plus, a special post-conference workshop on "Prion Clearance and Decontamination for Manufacturing Environments" explores the characteristics of the prion protein that make its control a challenge for manufacturers. The workshop is part of IBC's 2nd Annual Transmissible Spongiform Encephalopathies (TSEs) conference on November 16-17 also at the Hyatt Regency.

About IBC Life Sciences

IBC Life Sciences is an independent organizer that is in business to provide an unbiased forum for the evaluation of current research, market trends, technological developments and applications. IBC Life Sciences is part of IBC USA Conferences, Inc., a division of T&F Informa plc (London: TFI). T&F Informa was created through the merger of Informa Group plc and Taylor & Francis Group plc in May 2004. The two companies are market leaders in providing specialist information to commercial and academic markets through conferences and trade events, as well as the publication of academic, scientific and professional books, journals and newsletters.

To download the brochure, visit:

Contact Information

  • Contact:
    Andrew White
    IBC Life Sciences
    (508) 616-5550 Ext. 227
    Email Contact