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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 publication offers a guide through the complex landscape of regulations, standards, and interpretations surrounding software as a medical device.
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 inaugural issue of RF Quarterly. This new RAPS member-exclusive benefit features in-depth original, thematically curated content – along with tools and resources – on key areas and emerging issues in the global regulatory landscape. Articles are developed by global subject-matter experts representing a range of regulatory responsibilities and organizations. RF Quarterly replaces the former quarterly article series and is available in addition to the regular monthly Regulatory Focus feature articles.
Clinical trials are essential components of pharmaceutical research and development. In recent years, global clinical trials have moved centerstage, and while they offer many advantages for patients and sponsors, the logistics and complexities of operating in foreign countries are challenging. In this issue, regulatory experts examine clinical development planning, the regulations and guidelines governing local and multiregional clinical trials, good clinical practice and compliance, and clinical trial applications. A cluster of articles also addresses the importance of innovation and adaptability in initiating and maintaining clinical trials.
1 Introduction: Global clinical trials Renée Matthews HTML 5 Strategies for clinical development planning William Sietsema, PhD, and Eric Brass, PhD HTML 15 Clinical trials, good clinical practice, regulations, and compliance Anu Gaur, PhD, MBA, MSRA, RAC; Bettina Merz-Nideroest, MPharm; and Andrea Zobel, PhD, Dipl Biochem HTML 33 Planning for a clinical trial application Sharry Arora, MPharm HTML 40 Modernizing clinical trial regulations in Canada Tanya Ramsamy, PhD HTML 45 The Canadian application process and alternate pathway for COVID-19‒related trials Mukesh Kumar, RAC, and Melanie Oakley HTML 55 Initiating clinical trials in China: What foreign medtech companies need to do Hamish King, LLB, RAC HTML Upcoming in RF Quarterly