A NEW Member Benefit for 2021

2021 RF Quarterly Q1

RF Quarterly, June 2021: Artificial Intelligence
in global regulatory practice

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.

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Table of Contents

1    Introduction: Artificial intelligence in global regulatory practice
          Renée Matthews
4   Artificial intelligence:
      Characteristics, regulatory compliance, and legislation
         Koen Cobbaert, MSc
27  Modernizing medical devices regulation for AI and ML: GHWP efforts
           Abdullatif S. Al Watban, PhD
33  Regulatory update for SaMD and AI product approvals in China
           Hamish King, LLB, RAC
43  Enabling the digital transformation of industry: The roles of AI, big data,
        analytics, and related data ecosystem
           Wael William Diab, MS, MBA
48  Synthetic data and the innovation, assessment, and regulation of AI
        medical devices
           Puja Myles, MPH, PhD; Johan Ordish, MA; Richard Branson, MSc, MA
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:
  • Quality and Compliance in Regulatory Affairs (September; articles due 1 August 2021)
  • RAPS 2021 Convergence (December; articles based on presentations during 2021 Convergence)
 To contribute to the September RF Quarterly, email Renée Matthews rmatthews@raps.org.
For more information, see Guidelines for Authors and the 2021 Editorial Calendar.
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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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