Upcoming Biotechnology Law & Regulation Conference April 21, 2008
Posted by Reginald Johnson in Drugs, Education, Healthcare, Science, Technology.add a comment
The Food and Drug Law Institute will present their conference Introduction to Biotechnology Law & Regulation. This year’s program has been updated to include the latest requirements, as well as key changes to pre-existing requirements, imposed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
New this year is a section on the clinical trial database and postmarket safety requirements. Also, there will be a discussion on follow-on biologics. You will learn the organizational structure of FDA and obtain an overview of its regulatory process with regard to human biotechnology products, including biologicals, drugs and tissue. This is a program that will provide you with the basics of FDA regulation pertaining to the development, manufacturing, marketing and post-marketing requirements of biotechnology products including human biologicals and drugs.
You will become more familiar with many of the acronyms used in the biotechnology arena, such as VAERS, GLPs, GMPs, IND, NDA, ANDA, BLA and others.
Topics will also include section 505(b)(2) application regulations, as well as regulations related to expedited, fast track, and accelerated approval; responding to violations reported by FDA; advertising and promotion; import/export requirements and market exclusivity. Learn More >
The program will also help you comply with FDA’s regulations, and identify and address potential areas for regulatory problems. You will also acquire a basic overview of other administrative agencies involved with the regulation of human biotechnology products, and the framework of requirements they enforce. The program will enable you to get answers to your questions through lively audience participation.
Who Should Attend?
You should attend this program if you’re in regulatory affairs, from the legal community, or from a federal or state regulatory agency and need an overview on biotechnology law and regulation. The interactive nature of this workshop requires that attendance be limited. Early registration is recommended. This workshop will be held in an informal, classroom atmosphere where dialogue and questions will be encouraged. FDLI suggests that attendees dress comfortably in “casual business attire.”
Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.
Speakers
David G. Adams, Chairman, FDA Group, Venable, LLP
Donald O. Beers, Partner, Arnold & Porter LLP
Benjamin L. England, Attorney and Founder, FDA Imports
Jeffrey K. Francer, Assistant General Counsel, PhRMA
Edward L. Korwek, Ph.D., Partner, Hogan & Hartson, L.L.P.
Natasha V. Leskovsek, Partner, Heller Ehrman LLP
Dawn Shawger McCord, Attorney at Law, Sedgwick Detert
Moran & Arnold LLP
Deborah M. Shelton, Special Counsel, Sheppard, Mulllin,
Richter & Hampton, LLP
Additional speakers to be announced soon
