An Overview & Comparison of US and EU Pediatric Drug Development Regulations and Processes

Drug Discovery & Development, Life Sciences, Pharmaceutical Regulation,
  • Thursday, May 23, 2019

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.

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.

Speakers

Lynne Georgopoulos, RN, MSHS, RAC, Vice President Pediatric Development, Americas, Synteract

Lynne Georgopoulos is responsible for providing professional leadership to ensure compliance with FDA, EMA, and International Conference on Harmonization (ICH) regulations, and creation and execution of preclinical, clinical, and regulatory strategies to support pediatric clinical trials for Synteract clients. Ms. Georgopoulos draws on 28 years of increasing responsibility in clinical operations/development, regulatory affairs, project management and quality assurance with extensive R&D experience with both small molecules and protein therapeutics from investigational new drug (IND) application to new drug application (NDA)/biologics license application (BLA).

Prior to the integration with Synteract, Ms. Georgopoulos was a strong contributor to the leadership and team building of KinderPharm as Senior VP of Clinical Development and Regulatory Affairs. She managed the Clinical and Regulatory departments and other cross-functional groups to meet aggressive development timelines at KinderPharm. She has a Master of Science degree in Health Sciences in Regulatory Affairs from The George Washington University and is regulatory affairs certified through the Regulatory Affairs Professional Society. She has published on pediatric development both through the Regulatory Affairs Professional Society as well as TOPRA (The Organisation for Professionals in Regulatory Affairs) in Europe.

Message Presenter
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Martine Dehlinger-Kremer, PhD, Vice President Pediatric Development, Europe, Synteract

Dr. Martine Dehlinger-Kremer has 30+ years of experience in the clinical research industry, including 28 years of progressively higher levels of regulatory, medical affairs and pediatric leadership. She and Ms. Georgopoulos now lead the Center of Pediatric Development for Synteract. She has contributed to global development of numerous products, including orphan drugs and biosimilars. She has participated in 100+ New Drug Applications and Marketing Authorization Applications globally and in clinical studies across all phases.

She is an observer member of the Coordinating Group of the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) and a long-time member of its working parties. She has served as Chair of the Pediatric Working Group of EUCROF since 2008 and is also Chair of the European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party. As well, she is a member of the External Advisory Board of the International Children’s Advisory Network (iCAN) and is President of the European CRO Federation (EUCROF).

In August 2015, Dr. Dehlinger-Kremer was named one of PharmaVOICE 100’s Most Inspiring People in Life Sciences, which recognizes industry leaders for their impact, experience and advocacy in clinical research. She holds a Doctorate in Sciences, Master of Advanced Study in Neurophysiology degree and a Master of Science degree.

Message Presenter

Who Should Attend?

VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

  • Clinical Affairs
  • Clinical R&D
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

What You Will Learn

Participants will learn: 

  • About the main US and EU regulations pertaining to pediatric drug development
  • About the key FDA and EMA guidance documents to support pediatric drug development
  • Important pediatric considerations that should be addressed during development of pediatric drugs
  • How to develop a pediatric plan (PSPs and PIPs)

Xtalks Partner

Synteract

With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.

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