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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.
Develop and sustain a competent global regulatory workforce that drives good regulatory practice and policy to advance public health.
The RAPS Board of Directors is the governing, policy-making and strategic body that guides RAPS in serving the regulatory professional and the regulatory profession around the world. The Board of Directors has the legal and fiduciary responsibility to ensure the longterm viability and integrity of RAPS. The Board of Directors plays an integral role in maintaining a system of checks and balances that enables the organization to make strategic business decisions.
Volunteer for the RAPS Nominating Committee. Contact nominations@raps.org for more information.
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New EU regulatory changes are coming: Here’s what you need to know by Fink Densford, Medical Design & Outsourcing, 2 January 2019 --- HHS Recommends Co-Prescribing Naloxone With Opioids by Joyce Frieden, Medpage Today, 20 December 2018 Medtech Losers of 2019 by MDDI Staff, Medical Device and Diagnostics Industry, 17 December 2019 Waiting in the shadow of a no deal Brexit Manufacturing Chemist, 19 December 2018 MDR: Market disruption on the horizon MedTech Engine, 11 December 2018 FDA Approves NIH-Funded Genetic Database, Issues Draft Guidance on NASH Pharmacy Choice, 7 December 2018 Disruption of the Year: EU regulatory overhaul by Meg Bryant, MedTechDive, 3 December 2018
As the international leader for the healthcare regulatory profession, RAPS has initiated and supported the development of this code of ethics for the profession. Following a series of surveys and focus groups held over two years, a task force of volunteers was convened in February 2003. Their work, reviewed and shaped by many regulatory professionals, forms this code.
Read Code of Ethics