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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.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
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.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Regulatory tools for generic drug companies: Formal FDA meetings and controlled correspondence
22 September 2020
Manufacturer obligations applying to importers, distributors, or others under MDR and IVDR
21 September 2020
An overview of upstream manufacturing process and process controls for biologics drug substance: A cytokine case
09 September 2020
Regulatory Focus, August issue: Global clinical trials, clinical trial applications
01 September 2020
Initiating clinical trials in China: What foreign MedTech companies need to do
Current Chinese NMPA clinical pathways for medical device registration
31 August 2020
FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic
17 August 2020
Interacting with competent authorities during COVID-19 – A European perspective
07 August 2020
The Canadian application process and alternate pathway for COVID-19‒related clinical trials
04 August 2020
13 September 2020
25 September 2020
24 September 2020
22 September 2020
17 September 2020