The Regulatory Affairs Professionals Society (RAPS) 2002 Annual Conference and Exhibition on October 6--9, 2002, at the Hilton Washington in Washington, DC, will feature more than 100 sessions dealing with key healthcare regulatory issues, including FDA updates, hot topics, global perspectives and emerging technologies.

On Tuesday, October 8, RAPS will host a Town Hall Meeting focusing on ethics. Session speakers will examine today's critical issues in business and professional ethics and their meaning for the emerging regulatory profession. After the presentations, an open discussion with the presenters and audience will provide a forum for the issues to be examined and questions to be answered as the regulatory affairs profession develops a code of ethics.

On Wednesday, October 9, a panel of leading FDA and industry experts will discuss pending legislative efforts that will affect healthcare regulation and regulatory professionals. Special attention will be focused on the Preparing FDA for the 21st Century Medical Technology Act (HR 3580). The panel is expected to tackle a myriad of issues such as pediatric concerns, combination products, interagency agreements, expedited reviews for new medical technologies, and user fees, as well as other significant topics facing the healthcare product industry.

The keynote address on Monday, October 7 will be presented by Michael Hawley, principal investigator of the Things That Think Massachusetts Institute of Technology Media Lab. The MIT laboratory is investigating how computer power can be harnessed to serve people's needs in unobtrusive and integrated ways by being infused into everyday objects such as clothes, toys and tools. An example would be computer chips in clothing that not only would monitor an individual's vital signs but also send the information to a doctor's office or home computer for analysis. Such devices will not only have a tremendous effect on individuals but on existing systems and societal structures as well.

Once again, this year's conference will feature executive staff briefings from FDA's three major medical product centers--Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER)--that will examine key issues and initiatives critical to FDA, industry and the public. The directors of CDRH--Dr. David Feigal--and CBER--Dr. Kathryn Zoon--are expected to attend along with senior CDER staff representatives. The CDRH and CDER briefings will be on Monday, October 7, and the CBER presentation will be on Tuesday, October 8.

On the global stage, Dr. David Jefferys, chief executive of the UK Medical Devices Agency, will address revisions to European Union's regulation of medical devices and in another session speakers from Argentina and Brazil along with FDA's International Programs office will discuss issues in Latin America. Other international sessions will consider regulatory issues and challenges in China, Taiwan, Japan, Australia and New Zealand, revisions to European pharmaceutical legislation, the proposed European Union tissue directive, and new clinical trial initiatives in Canada.

Sessions during the three-day conference will explore a wide range of regulatory issues dealing with drugs, devices, biologics, in vitro diagnostics, and global, clinical and legal concerns. In the research arena, one session will examine the regulation of cellular therapies and combination products, while another looks at issues surrounding therapeutic proteins. Also under discussion are advances in genetics and the technology's effect on regulation, vaccine development, regulatory oversight of Institutional Review Boards and clinical trials, recent legislation regarding generic pharmaceuticals, regulatory intelligence, mergers and acquisitions, FDA enforcement, the First Amendment and FDA regulation of advertising and promotion, product liability, combination products, US tissue policies and practices, dietary supplement and functional food regulation, and veterinary products.

For more information about the conference, click here.