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A NEW Member Benefit for 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.
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
15 ICH implementation: The transition from convergence to harmonization
Jerry Stewart, JD, MS, RPh; Theresa Mullin, PhD; and Petra Doerr, PhD
23 Pediatric drug development: Increasing success and overcoming obstacles
Linda McBride, RPh, RAC; Karl-Heinz Huemer, MD, PhD; and
Kimberly Belsky, MS
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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