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The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products - WCBP 2016. The meeting will be held on January 26, 2016 at The Mayflower Hotel, 1127 Connecticut Ave NW, Washington, D.C.

The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products - WCBP 2016. The meeting will be held on January 26, 2016 at The Mayflower Hotel, 1127 Connecticut Ave NW, Washington, D.C.

Goals and Objectives:

  • To provide a forum for discussing the latest bio-analytical methods and their practical application to biotechnological pharmaceuticals and other health-related products.
  • To provide a forum for open discussion between regulators of biotechnology-derived drug products (BPs) and developers of analytic methodologies for the development of BPs.
  • To seek feedback from industry, academia, government, and other stakeholders on advancements in bio-analytical methods and their application to BPs.
  • Promote the efficient development of BPs, including FDA=regulated therapeutic protein products and matters related to their development and regulation, such as novel analytical technologies, manufacturing issues, control strategies, immunogenic assessment, and sterility assistance issues.
  • Facilitate open discussions among the pharmaceutical / biotechnology industry and academic attendees and FDA and international regulatory staff.
  • To provide a forum to discuss among the pharmaceutical / biotechnology industry and academic attendees and FDA and international regulatory staff.
  • To provide a forum to discuss the scientific technical issues concerning characterizing complex biotechnology derived health products through panel discussions, presentations, and workshops.
  • To provide a venue for professionals to present their most current data and thoughts on BP analysis and regulation, with data presented in poster sessions.
  • To provide an opportunity for networking with other scientists.
Who Should Attend:
Drug development and regulatory professionals who have an interest in the safety, efficacy, and quality of BPs should attend this meeting. Attendees should include representatives of research and development, regulatory science, academia, quality assurance / quality control (QA/QC), and corporate management. Given the complexities of BP development, production and regulation, along with the broad range of therapeutic applications and medical contexts in which their complexities may be manifest, analytical and regulatory scientists from industry, academia, and government should use the proposed meeting as a venue for interacting and networking.
 
Contact
Harry Smith, The Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Building 51, room 4174, Silver Spring, MD 20903, 301-796-4442; email harry.smith@fda.hhs.gov.