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North Carolina Regulatory Affairs Forum

NCRAF is an association of regulatory affairs professionals centered in the Raleigh-Durham-Chapel Hill "Triangle" of North Carolina USA. NCRAF is dedicated to providing education and support for the continuing professional development of individuals who have an interest in regulatory affairs activities as they apply to research, development, or manufacture of drugs, biologics, or medical devices.

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Monthly Seminar

May 20, 2021

6:30 - 8:00 pm via Zoom

Regulatory Strategies in Global Pediatric Drug Development

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.


Speaker:

Edit Muhari-Stark, MD, MS; Medical Director, BioCryst Pharmaceuticals

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.

 


REGISTRATION
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2021 RAC Workshops

REGISTRATION IS OPEN!! 

Matierials and Recordings are available for each workshop to those registered.

Each series is a separate registration and fee!

Please don't try to tackle both at the same time.  Seriously.  Just pick ONE.

Pharma/Bio (or) Devices

Workshops Syllabus
REGISTER

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Membership dues for 2021 will be $20 for the year.

 

When your membership renewal comes up during the 2021 calendar year, you will receive, via email, an invoice for $20.
Please pay via the invoice, the old "log in to the website and renew" is no longer available.