Pharmaceutical regulatory professionals from around the world will join together for 2011 RAPS: The Regulatory Convergence in Indianapolis, USA, from October 22–26.
The premier annual event from the Regulatory Affairs Professionals Society (RAPS), the event presents an opportunity for regulatory professionals and thought leaders from industry, regulatory agencies, academia and other stakeholder organisations to exchange ideas.
“This conference is the key event of the year for the regulatory profession,” said RAPS Executive Director, Sherry Keramidas.
“No other gathering focuses on regulatory issues, developments and thought leadership in the global healthcare product sector like The Regulatory Convergence.
“In addition, with attendees and regulators from so many parts of the international regulatory community, the conference has become more globally focused and universally relevant than ever.”
2011 RAPS attendees will hear from top officials from the European Medicines Agency (EMA), European Commission and US Food and Drug Administration (FDA), as well as regulators from The Netherlands, China, Japan, Korea, Canada, Australia, Mexico, India, Saudi Arabia, Singapore and Taiwan.
Expert presenters will cover regulatory implications across a range of topics, including the latest developments in biotechnology, the regulatory pathway for biosimilars, regulation of software and mobile applications as medical devices, clinical evidence for combination products, drug delivery systems for biologic therapeutics, social media communications for medical products, 510(k) reform, global postmarket surveillance, regulatory considerations in the development of oncology drugs, business impacts of regulatory milestones and the role of regulatory at companies ranging from small start-ups to large multinationals.
Sessions such the EMA update and one covering the EU medical device recast are expected to draw keen interest.
Conference sessions are organised by subject-matter tracks in biologics/biotechnology, clinical, compliance, electronic intervention, health-related foods, medical devices and in vitro diagnostics, pharmaceuticals and regulatory business.
Workshops will offer additional instruction on essentials of regulatory affairs for both the US and the EU, regulatory strategy, combination products, over-the-counter drugs and generics, as well as a regulatory managers’ boot camp.