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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.
  
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Previous issues

• Global clinical trials
• Artificial intelligence in regulatory affairs
• Quality and compliance

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