An Overview Comparison of US and EU Pediatric Drug Development Regulations and Processes, Upcoming Webinar Hosted by Xtalks

09:00 EDT 3 May 2019 | PR Web

This webinar will provide an overview of key pediatric regulations and guidelines that pertain to the development of pediatric drugs for the US and European markets. The featured speakers from Synteract have extensive knowledge and experience working globally on pediatric drug development.

TORONTO (PRWEB) May 03, 2019

The live webinar takes place on Thursday, May 23, 2019 at 11am EDT (4pm BST/UK) with guest speakers from Synteract, Lynne Georgopoulos, RN, MSHS, RAC, Vice President of Pediatric Development, Americas and Martine Dehlinger-Kremer, PhD, Vice President of Pediatric Development, Europe.

For years, proponents for improved access to healthcare have advocated to include pediatric populations in clinical research. Experts argued that excluding children from this process causes harm by withholding important therapies, due to lack of a method to accurately assess safety and efficacy and the custom of using drugs off-label. Today, after years of neglect, the development of drug products for pediatric patients is increasingly integrated into the overall development process.

The evolution of pediatric guidance and regulations in the US and EU has had a positive impact on fostering research and generating new treatment options for pediatric patients over the past decade. However, in many cases, there is still a significant (7 to 10 year) lag from the time an initial drug is approved in adults to the inclusion of some pediatric-specific information on the product label. The time lag is even greater for infants and neonates.

Don’t miss this opportunity to learn about important pediatric drug development regulations in the U.S. and EU.

For more information or to register for this event, visit An Overview & Comparison of US and EU Pediatric Drug Development Regulations and Processes.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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