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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.
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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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.
6-Dec-17 - As EU Regulations Undergo Major Changes, RAPS Publishes Updated Essential Regulatory Affairs Reference 12-Sep-17 - RAPS Switzerland Chapter Becomes Official Nonprofit Association Under Swiss Law 22-Aug-17 - Six Highly Accomplished Regulatory Professionals to Join the Ranks of RAPS Fellows 17-Aug-17 - RAPS Honors Regulatory Leaders With Two New Awards 16-Aug-17 - RAPS Publishes 10th Edition of Essential Text on US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices and Biopharmaceuticals 11-Aug-17 - 192 Earned Regulatory Affairs Certification (RAC) in Spring 2017 10-Aug-17 - FDA Commissioner Scott Gottlieb’s Keynote Among Highly Anticipated Sessions at RAPS Regulatory Convergence 3-Jul-17 - FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence 18-May-17 - RAPS and Industry Experts Join Forces for Dedicated MDR Workshop 20-Apr-17 - World's Largest Society for Regulatory Professionals Increases Investment in Europe 28-Mar-17 - RAPS Seeks Applications for 2017 Fellows 11-Jan-17 - RAPS' New Board of Directors Begins 2017 Term
Learn More
20-Dec-17 - FDA bans 24 ingredients from hand soaps, antiseptic washes - Becker's Clinical Leadership & Infection Control 12-Dec-17 - The Role Of Modeling & Simulation In Clinical Trials - Clinical Leader 5-Dec-17 - How will the pharma industry fare in 2018 under Trump? - MM&M 24-Nov-17 - TRUMP NOMINATES DRUG EXECUTIVE AZAR AS HHS HEAD - Orthopedics This Week 22-Nov-17 - FDA REQUIRED ESSURE BOXED WARNING AND POST-MARKET STUDY - Top Class Actions 3-Nov-17 - Republican Tax Plan Has Far-Reaching Implications For Healthcare Stakeholders - AJMC 27-Oct-17 - FDA ISSUES “BREAKTHROUGH DEVICES” GUIDANCE - Orthopedics This Week 6-Oct-17 - FDA Awards $10M in Grants for Rare Disease Natural History Studies - Genetic Engineering & Biotechnology News 4-Oct-17 - FDA offering new guidance to medical device makers - Radiology Business 28-Sep-17 - Gottlieb Speaks to RAPS Regulatory Conference - Policy and Medicine 14-Sep-17 - FDA’s Gottlieb wants drug pricing and drug development costs to come down - Chemical & Engineering News 12-Sep-17 - FDA commissioner: We need to talk about drug development costs - FierceBiotech 12-Sep - Trautman says purchasing controls are fair game for MDSAP audits - Medical Device Daily 11-Sep-17 - Study says drug development costs much less than previously estimated - MM&M
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