Pediatric Clinical Trials Regulation - Webinar CD/Transcript

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Pediatric Clinical Trials Regulation: Latest FDA and International Compliance Developments

What do drug developers need to know about regulatory changes to pediatric trials?

Join Dr. Martine Dehlinger-Kremer — Global Vice President, Medical & Regulatory Affairs at SynteractHCR — for a 90-minute session where she’ll help attendees understand the landscape for pediatric drug development.

After listening to this webinar, you’ll be able to:

  • Fully comply with FDA’s recent draft guidance on iPSPs, including when an iPSP must be submitted and what should be included in an iPSP
  • Understand the impact of deferrals and waivers to planned pediatric clinical trials requests
  • Comply not only with the technical requirement for pediatric clinical trials mandated by the International Council on Harmonization but those mandated by the EWG Working Group addendum, which included input from the US, EU, Japan, and Canada.
  • Streamline paperwork on pediatric clinical trials in conjunction with the recently implemented guideline on the application of PIPs.

Understand the regulations you need to comply with in order to submit your pediatric drugs for approval. Order today.

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers

Dr. Martine Dehlinger-Kremer, Global Vice President, Medical & Regulatory Affairs, SynteractHCR
In addition to providing top-level leadership for her company to the Medical and Regulatory Affairs functions, inclusive of Medical Operations, Feasibility, Medical Advice, Medical Monitoring, and Regulatory Affairs, Dr. Dehlinger-Kremer is also Chair of the Pediatric Working Group of EUCROF, the EU CRO Federation. She is also an active member of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) and an active member of the EFGCP Children Working Party.