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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.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Whether you are looking for an undergraduate, graduate or certificate program, there are colleges and universities around the world offering programs tailored to your specific needs. For additional information about the programs listed below, please contact the universities directly.
Note: The following list does not constitute a RAPS endorsement of these particular programs.
Arizona State University, Phoenix, AZ Master of Science in Clinical Research Management Concentration in Regulatory Science Graduate Certificate in Clinical Research Management These programs are also available completely online. Online programs may be accessed here.
California State University Fullerton, Fullerton, CA Master of Science in Applied Biotechnology University Extended Education Certificate Program in Pharmaceutical Engineering University Extended Education Certificate Program in Pharmaceutical Product Lifecycle Risk Management (classroom and online courses available)
Campbell University School of Pharmacy, Buies Creek, NC Bachelor of Science in Clinical Research (BSCR) and Master of Science in Clinical Research Drexel University, Philadelphia, PA – Online Programs MS in Clinical Research Organization and Management MS in Clinical Research for Health Professionals MS in Drug Discovery and Development Certificate of Study in Clinical Research Certificate in Drug Discovery and Development Quantitative Principles for Clinical Research Certificate
George Washington University, Washington, DC Graduate Certificate in Regulatory Affairs Master of Science in Health Sciences in Regulatory Affairs
Hood College, Frederick, MD Certificate in Regulatory Compliance
Indiana University Kelley School of Business, Bloomington, IN Kelley Executive Certificate in the Business of Life Sciences
Johns Hopkins University, Baltimore and Rockville, MD Master of Science in Biotechnology with a concentration in Regulatory Affairs Master of Science in Bioscience Regulatory Affairs (Both degree programs can be completed entirely online or onsite) BD Diagnostics Regulatory Affairs Fellowship
Keck Graduate Institute, Claremont, CA Master of Business and Science (MBS) with emphasis in Clinical Regulatory Affairs
Lehigh University, Bethelem, PA Certificate in Regulatory Affairs
Long Island University—Arnold and Marie Schwarzt College of Pharmacy, Brooklyn, NY Master of Science with a specialization in drug regulatory affairs
Loyola University Chicago, Chicago, IL Master of Jurisprudence in Health Law Master of Laws in Health Law
Massachusetts College of Pharmacy, Boston, MA Master of Science in Drug Regulatory Affairs and Health Policy
Northeastern University, College of Health Science & College of Science, Boston, MA Master of Science in Biotechnology Master of Science in Biopharmaceutical Regulatory Science
Northeastern University, School of Professional & Continuing Studies, Boston, MA Master of Science in Regulatory Affairs Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs Graduate Certificate in Biopharmaceutical International Regulatory Affairs Graduate Certificate in Medical Devices Regulatory Affairs
Northeastern University, Toronto Campus, Toronto, ON Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
Northwestern University School of Continuing Studies, Chicago, IL Master of Science in Regulatory Compliance Master of Science in Clinical Research and Regulatory Administration
Ohio State University, Columbus, OH Master of Applied Clinical and Preclinical Research (program offered 100% online)
Rutgers, The State University of New Jersey Professional Science Master’s Program, New Brunswick/Newark/Camden, NJ Master of Business & Science Graduate Certificate in Pharmaceuticals & Clinical Trials Management Graduate Certificate in Science & Technology Management
San Diego State University, San Diego, CA (Regulatory Science) Advanced Certificate in Regulatory Affairs Master of Science in Regulatory Affairs
St. Cloud State University, Plymouth, MN Master of Science in Regulatory Affairs and Services, with focus on medical devices Master of Science in Applied Clinical Research, designed specifically for industry Master of Science in Medical Technology Quality, covering Medical Device Quality Assurance in Design, Development, Production, Installation, and Servicing
St. Johns University, New York, NY Master's in Pharmacy Administration with a specialization in Pharmaceutical Marketing and Regulatory Affairs/Quality Assurance
Temple University, Philadelphia, PA Master of Science in Quality Assurance/Regulatory Affairs and Post-Master's certificate in Advanced Quality Assurance or Regulatory Affairs
Texas A & M University, College Station, TX Graduate Certificate in Regulatory Science Hazard Analysis and Preventive Controls for Feed
University of California, Berkeley Extension, CA Professional Program in Regulatory Affairs Professional Program in Quality and Compliance for Biotechnology Certificate Program in Clinical Research Conduct and Management (classroom or fully online)
University of California, San Diego Extension, San Diego, CA Certificate in Regulatory Affairs Essentials and Certificate in Regulatory affairs for the Biomedical Industry
University of California, Irvine Division of Containing Education, Irvine, CA Certificate in Medical Product Development (online) Certificate in Clinical Trials: Medical Device and Drug Development (online) Certificate in Clinical Research (classroom) Regulatory Affairs and Compliance (online) University of California, Santa Cruz Extension in the Silicon Valley, Cupertino, CA Regulatory Affairs Certificate Program (including drug and device tracks) Clinical Trials Design and Management Certificate Program Biotechnology Certificate Program Bioscience Business and Marketing Certificate Program
University of Florida College of Pharmacy, Gainesville, FL Master's Degree Program in Pharmacy Online Graduate Certificate Program
University of Georgia, Athens, GA Master of Science in Regulatory Sciences (Thesis Track and Project Track) Graduate Certificate in Regulatory Sciences Graduate Certificate in Clinical Trials Design and Monitoring
University of Maryland, School of Pharmacy, Baltimore, MD Masters of Science in Regulatory Science
University of Maryland, Baltimore County, Baltimore, MD Post-Baccalaureate Certificate in Biochemical Regulatory Engineering University of North Carolina Wilmington, Wilmington, NC Undergraduate Clinical Research Minor in Clinical Research Clinical Research Operations Post-Baccalaureate Certification Master of Clinical Research and Product Development
University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA Master of Regulatory Affairs Master of Science in Regulatory Science
University of Rhode Island, Kingston, RI MS/PhD Program in Pharmaceutics and Pharmacokinetics University of the Sciences, Philadelphia, PA The University of the Sciences Biomedical Writing Certificate in Regulatory Writing
University of Southern California, Los Angeles, CA Master of Science in Regulatory Science Master of Science in Management of Drug Development Master of Science in Medical Product Quality Certificate Program in Clinical Research Design and Management Certificate Program in Food Safety Certificate Program in Patient and Product Safety Certificate in Preclinical Drug Development Certificate in Regulatory and Clinical Affairs Certificate in Medical Product Quality
University of St. Thomas, St. Paul, MN MS in Regulatory Science Certificate in Medical Device Development
University of Washington Certificate Program in Biomedical Regulatory Affairs Master of Science in Biomedical Regulatory Affairs
University of Wisconsin-Madison, Department of Engineering Professional Development, Madison, WI Regulatory affairs, quality assurance, pharmaceutical engineering (classroom and on-site)
Cranfield University, United Kingdom MSc Medical Technology Regulatory Affairs
Danube University Krems, Austria EU Regulatory Affairs Certificate & Master of Science Program
TOPRA in conjunction with the University of Hertfordshire Postgraduate Diploma and MSc in Regulatory Affairs offered by TOPRA and validated by the University of Hertfordshire
University of Bonn, Bonn, Germany Certificate of Master of Drug Regulatory Affairs
Humber College, Toronto, Ontario Regulatory Affairs Postgraduate Certificate
Seneca College, Toronto, Ontario Pharmaceutical Regulatory Affairs and Quality Operations Graduate Certificate
UNSW Sydney Master of Pharmaceutical Medicine This degree is fully online and covers all aspects of therapeutic product development including several courses in regulatory affairs.