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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.
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.
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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
US-focused regulatory toolbox: The basics
21 October 2020
16 October 2020
Starting out: A beginner’s toolkit of US regulatory resources
14 October 2020
Getting to the point: Achieving clear communication with health authorities
09 October 2020
A regulatory anomaly: The NDA for water
07 October 2020
September’s Regulatory Focus: Countdown to EU MDR and IVDR
02 October 2020
Implementing the MDR: Slowing down on the homestretch?
01 October 2020
IVDR, notified bodies, and technical documentation: The devil is in the detail
Regulation of cell and gene therapy products in China
30 September 2020
MDR, IVDR, and compliance: A guide for distributors
28 September 2020
23 October 2020
22 October 2020