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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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
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.
Regulatory affairs professionals play pivotal roles in ensuring healthcare products adhere to regulations and in gaining regulatory approval for product manufacture and sales. They must understand the science and technology connected with a product, the company's business goals, and, most importantly, the nuances of national and international regulations and guidance related to the product.
Regulatory affairs can be daunting, but newcomers don't need to go it alone. With RAPS’ Onboarding Essentials, those transitioning into regulatory gain fundamental knowledge with a comprehensive education designed by RAPS globally recognized experts.
Build a broad foundational knowledge base with a dynamic toolkit that promotes your regulatory development and success. RAPS' Onboarding Essentials offer everything you need to accelerate your career in regulatory affairs:
Build a broad foundational knowledge base with this dynamic toolkit that promotes your regulatory development and success. Accelerate your career in regulatory affairs.
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The Regulatory Affairs Certificate Programs are online courses you can personalize to meet your professional development needs. These general studies pathways include four core modules that are required and five electives. This comprehensive education that promotes in-depth understanding of regulatory skills in pharmaceuticals, medical devices, or both.
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Our Fundamentals series puts all the information you need right at your fingertips. Each is designed to provide the basics across the full product lifecycle, with precise indexing to save you time and effort. If you work in regulatory in multiple markets or are learning about a new product line, Fundamentals make life a lot easier.
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Our online courses provide regulatory education from anywhere at any time. These introductory courses are recommended for your onboarding needs.
Introduction to Regulatory Affairs in the US and Canada
Introduction to Regulatory Affairs in the EU
Medical Devices: Definition & Lifecycle
Pharmaceuticals: Definition & Lifecycle
Global Regulatory Strategy for Pharmaceuticals
Medical Devices: US Regulations
Medical Devices: EU Regulations
Pharmaceuticals: US Regulations
RAPS Regipedia includes more than 2,000 definitions from a variety of sources, specifying the region for each, and cross-referenced for easy use. It provides the most comprehensive and up-to-date terminology across the US, EU, Canada and international markets and is an essential reference for novice and seasoned regulatory pros.
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