A NEW Member Benefit for 2021

RF Quarterly

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.

RF Quarterly, March 2021: Global clinical trials

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.

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Table of Contents

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

The RF Quarterly series is published in March, June, September, and December. The themes and due dates for article submissions for upcoming issues during 2021 will be:
 

• Artificial Intelligence in Regulatory Affairs (June)
• Quality and Compliance in Regulatory Affairs (September)
• RAPS 2021 Convergence (December; articles based on presentations during 2021 Convergence)

 To contribute to the June or September RF Quarterly, email Renée Matthews rmatthews@raps.org.
 
For more information, see Guidelines for Authors and the 2021 Editorial Calendar.
  
Join now to view the current issue of RF Quarterly 
 
Access more benefits in the former Article Series  on the following topics:

• Regulatory Intelligence
• The Shifting Global Regulatory Landscape
• Global Regulatory Strategies and Best Practices
• The Strategic Role of the Regulatory Professional
• Risk Management and Quality
• Global Strategies for Drugs and Devices
• Executive Leadership and Management
• Global Regulatory Policy and Strategy

 
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