“Medical device companies must interact with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and any number of the other agencies that regulate medical devices around the world,” said RAPS Executive Director Sherry Keramidas, PhD, CAE. “Knowing how to develop an effective global regulatory strategy is an essential skill for all regulatory professionals, and this forum will help attendees better understand what they must do in crafting their strategies in order to maximize their companies’ commercial opportunities and minimize risk.”
Important topics to be covered include global differences in submission formats and filing strategies, how to monitor and revise a regulatory strategy, regulatory intelligence gathering, business partnerships and the essential elements of a Global Regulatory Strategy Document (GRSD) and Design Dossier.
Featured speakers for RAPS’ Regulatory Strategy Forum for Medical Devices include Brad Hossack, international vice president, international regulatory affairs, Boston Scientific Corporation; Patrick Johnson, senior director, regulatory affairs, Medtronic Neuromodulation; and Mark Kramer, RAC, president, Regulatory Strategies Inc.
More information and a full agenda can be found online at http://www.raps.org/Education-amp-Training/RAPS-Meetings-amp-Education-Calendar/Regulatory-Strategy-Forum-for-Medical-Devices.aspx. About RAPS 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. http://www.RAPS.org
