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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.
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.
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.
Stay informed on the latest healthcare regulatory news through RAPS’ online magazine, Regulatory Focus and its companion daily e-newsletter RF Today, or by following RAPS on social media, including Twitter, LinkedIn and Facebook.
Reporters, bloggers and other members of the media interested in covering RAPS events or programs should contact Zachary Brousseau, senior manager of communications, at zbrousseau@raps.org or by calling +301 770 2920 ext. 245.
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
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