News Releases

News Releases

Global Experts to Address Navigating Pediatric Drug Development Regulations in the U.S. and EU in Synteract Webinar

RESEARCH TRIANGLE PARK, NC May 20, 2019Synteract, an innovative CRO partnering with biotech and pharma companies to bring new medicines to market, will hold a Webinar covering updates in pediatric drug development regulations in the U.S. and EU. The Webinar, “An Overview & Comparison of US and EU Pediatric Drug Development Regulations and Processes,” will be presented free to attendees Thursday, May 23, 2019 from 11 a.m. – 12:00 p.m. Eastern Time.

Over the past decade, evolution of pediatric guidance and regulations in the U.S. and EU has had a positive impact on fostering research and new treatment options for children. However, navigating emerging requirements can be challenging. Synteract experts Lynne Georgopoulos, RN, MSHS, RAC, vice president of Pediatric Development, Americas, and Martine Dehlinger-Kremer, PhD, vice president of Pediatric Development, Europe, will provide insights on what drug developers need to know regarding FDA and EMA guidance and pediatric plans for the US and EU.

“Pediatric development plans are now a requirement for all new medicines that do not have a waiver in the U.S. and EU. New regulations are emerging that seek to aid drug developers in finding the right balance between protecting children and enabling research to help them to benefit from safe, efficient medicines,” said Dr. Dehlinger-Kremer. “Lynne and I look forward to discussing both current and emerging regulations and what drug developers need to know to stay on top of requirements in this evolving field.”

Register Now to learn how to make a positive impact in your next pediatric trial. 

About Synteract
“Bringing Clinical Trials to Life” represents Synteract’s commitment to engage with drug developers, patients, investigators, and regulatory experts, to bring insights to action and make better therapies a reality. With 800 employees across 21 countries, Synteract supports biotech and pharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted nearly 4,000 studies on six continents and in more than 60 countries. It has contributed to more than 240 product approvals. Synteract offers a notable depth of therapeutic expertise in oncology, dermatology, neuro degenerative, pediatrics, and rare and orphan diseases. Connect on LinkedIn and Twitter.

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CONTACT:
Hilary McCarthy
hilary@clearpointagency.com
508-829-2543

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