Regulatory Strategies in Global Pediatric Drug Development hosted by NCRAF
Date and Time
Thursday May 20, 2021
6:30 PM - 8:00 PM EDT
May 20
6 - 8:30 p.m.
Location
Zoom
Fees/Admission
Website
Regulatory Strategies in Global Pedi...
Description
Edit Muhari-Stark, MD, MS
Medical Director, BioCryst Pharmaceuticals
This presentation will provide a brief overview of the most important pediatric regulatory procedures in the US and EU, as well as in the UK post-Brexit. The focus will be on global pediatric regulatory strategy: international regulatory agency collaboration on pediatric topics, pediatric submission timings, potential pitfalls, and tips on how to increase your chances at achieving convergent opinions from pediatric review committees.
Edit Muhari-Stark, MD, MS is a medical director at BioCryst Pharmaceuticals, where she oversees the pediatric aspects of development programs. Edit is a pediatrician by training with 4 years clinical experience in the UK. Subsequently she joined the Medicines and Healthcare Products Regulatory Agency (MHRA) Paediatric Unit in London and became an MHRA accredited medical assessor in 2013. Her role included Paediatric Investigation Plan (PIP) assessments, presentations at EMA PDCO meetings, Article 45 and 46 submissions, and pediatric safety reviews. In 2016, she received her ‘MSc in Paediatric Medicines Development and Evaluation’ at the University of Rome Tor Vergata in Italy. The MSc program included a 4-month long research fellowship at the FDA Office of Clinical Pharmacology in Silver Spring, MD. She also highly values the importance of pediatric research networks and serves as a board member of Medicines for Children Research Network (MCRN) Hungary since 2014. Edit relocated to the Triangle area from Europe in 2016, and after running her own consultancy (PedMed Consulting) for a few years, she joined BioCryst Pharmaceuticals in 2019.
