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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
5 Strategies for clinical development planning
William Sietsema, PhD, and Eric Brass, PhD
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
33 Planning for a clinical trial application
Sharry Arora, MPharm
40 Modernizing clinical trial regulations in Canada
Tanya Ramsamy, PhD
45 The Canadian application process and alternate pathway for COVID-19‒related trials
Mukesh Kumar, RAC, and Melanie Oakley
55 Initiating clinical trials in China: What foreign medtech companies need to do
Hamish King, LLB, RAC
Upcoming in RF Quarterly