A NEW Member Benefit for 2021

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.

Login now to view RF Quarterly 

Table of Contents

1    Introduction
          Renée Matthews
          HTML
 
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
         HTML
 
15  ICH implementation: The transition from convergence to harmonization
           Jerry Stewart, JD, MS, RPh; Theresa Mullin, PhD; and Petra Doerr, PhD
           HTML
  
23  Pediatric drug development: Increasing success and overcoming obstacles
           Linda McBride, RPh, RAC; Karl-Heinz Huemer, MD, PhD; and
           Kimberly Belsky, MS
           HTML
 
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
           HTML

 
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

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

Not a RAPS Member? RAPS Membership gives you access to countless resources and a vast network of professional all dedicated to regulatory.  
Learn more about RAPS Membership and Benefits.