Rockville, MD USA—Regulatory, business, government and academic leaders met in Vancouver last month for the 2011 RAPS Horizons conference, convened by the Regulatory Affairs Professionals Society (RAPS), to discuss some of the most pressing issues facing healthcare systems around the world and how regulatory professionals can best help in addressing these challenges. Today, RAPS released a statement, entitled Regulatory on the Horizon, summarizing some of the key issues identified at the conference, setting the stage for deeper examination in an upcoming series of reports and papers.
“Regulatory professionals, who have a hand in every stage of the healthcare product lifecycle, can and must play a vital role in solving many of healthcare’s most critical challenges,” writes RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, in the statement.
Horizons attendees identified the following four broad areas of concern confronting healthcare for which regulatory professionals can provide needed expertise and help craft solutions:
- Economic issues, including the need to address complex demands of patients, payers, manufacturers and regulators, and to control costs while fostering innovation
- Advances in science and technology, recognizing the need for regulation to keep pace with the latest medical innovations and adapt quickly to meet public health needs
- Globalization, including efforts to harmonize regulations among regulatory systems and maximize efficiencies while monitoring the global supply chain for pharmaceuticals, biologics and other healthcare products
- Trust and transparency among all stakeholders were identified as critical for advancing public health
A PDF file of the full statement is posted on RAPS.org and can be downloaded at http://www.raps.org/Portals/0/Documents/2011Horizon_Regulatory_Article.pdf.
More in-depth discussion and analysis will be conducted throughout the year, with an initial white paper expected in late June.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org