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A NEW Member Benefit for 2021

2021 RF Quarterly Q1

RF Quarterly,  December 2021: Selected takeaways from RAPS Convergence 2021

Welcome to the December issue of RF Quarterly which focuses on key takeaways from the RAPS Convergence 2021, including patient-focused approaches in regulatory decision making and drug development, the transition from convergence to harmonization for global pharmaceutical regulatory requirements, pediatric drug development, and regulatory and clinical strategies.

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Table of Contents

1    Introduction
          Renée Matthews
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4   Patient-reported outcomes and patient preference information in
      regulatory decision making
         Richard Jahn, JD, MS; Bert Regeer, MD; Brett Hauber, PhD;
         Nathalie Bere, MPH; and Theresa Mullin, PhD
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15  ICH implementation: The transition from convergence to harmonization
           Jerry Stewart, JD, MS, RPh; Theresa Mullin, PhD; and Petra Doerr, PhD
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23  Pediatric drug development: Increasing success and overcoming obstacles
           Linda McBride, RPh, RAC; Karl-Heinz Huemer, MD, PhD; and
           Kimberly Belsky, MS
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30  Regulatory strategy and clinical strategy: Where do they converge and diverge?
           Angela Mallery, EdD; and
           Pamela Wolfe, MBA, MS, CCRP, ACRP-CP, ACRP-MDP, FACRP
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Upcoming in RF Quarterly
  • Software as a medical device (March 2022)
  • Regulatory history (June 2022)
  • Strategy in regulatory affairs (September 2022)
  • RAPS 2021 Convergence (December 2022)
To contribute to the upcoming issues, email rmatthews@raps.org.
 
For more information, see Guidelines for Authors and the 2022 Editorial Calendar.
  
Join now to view the current issue of RF Quarterly 
 
Previous issues
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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