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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.
Euro Convergence 2020 is moving towards a rewarding week. We are now offering an enhanced hybrid format with both in-person and online sessions from Monday 26 to Friday 30 October 2020.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
The Canadian application process and alternate pathway for COVID-19‒related clinical trials
04 August 2020
Regulatory Focus, July issue: Cell and gene therapy
02 August 2020
Advanced therapies: ‘Trip hazards’ on the development pathway
A military-civilian perspective on real-world evidence to support regulatory decision making
29 July 2020
Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy
US regulations for regenerative medicine advanced therapies
24 July 2020
Recasting CAPA as a continuous improvement process
Designing a biologics manufacturing facility: Early planning for success
22 July 2020
Regulation of advanced therapy medicinal products in the EU
16 July 2020
Update on RMAT designations
15 July 2020
Managing uncertainty: Regulatory reporting in multinational trials during COVID-19
13 July 2020
11 August 2020
10 August 2020
11 August 2020
06 August 2020