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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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This brand new book offers practical guidance on navigating this exciting area of converging technologies.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
A NEW Member Benefit for 2021
Welcome to the summer issue of RF Quarterly in which international experts from the UK, EU, Saudi Arabia, Hong Kong, and the US have come together to examine and dissect the role artificial intelligence (AI) in healthcare, its impact on global regulatory practice, and efforts to address challenges such as harmononization and standardization, bias, generalizability, and others.
1 Introduction: Artificial intelligence in global regulatory practice Renée Matthews HTML 4 Artificial intelligence: Characteristics, regulatory compliance, and legislation Koen Cobbaert, MSc HTML 27 Modernizing medical devices regulation for AI and ML: GHWP efforts Abdullatif S. Al Watban, PhD HTML 33 Regulatory update for SaMD and AI product approvals in China Hamish King, LLB, RAC HTML 43 Enabling the digital transformation of industry: The roles of AI, big data, analytics, and related data ecosystem Wael William Diab, MS, MBA HTML 48 Synthetic data and the innovation, assessment, and regulation of AI medical devices Puja Myles, MPH, PhD; Johan Ordish, MA; Richard Branson, MSc, MA HTML Upcoming in RF Quarterly