FDAnews Announces — Pediatric Clinical Trials Regulation: Latest FDA and International Compliance Developments Webinar, Sept. 7, 2016

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What do manufacturers need to take into account for pediatric trials and drug development? Join Dr. Martine Dehlinger-Kremer, Global Vice President, Medical & Regulatory Affairs at SynteractHCR, for a 90-minute webinar on Sept. 7 where she’ll help attendees understand the landscape for pediatric drug development.

Pediatric Clinical Trials Regulation:
Latest FDA and International Compliance Developments
**An FDAnews Webinar**
Sept. 7, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/pediatricctreg        

What do manufacturers need to take into account for pediatric trials and drug development?

Join Dr. Martine Dehlinger-Kremer — Global Vice President, Medical & Regulatory Affairs at SynteractHCR — for a 90-minute webinar on Sept. 7 where she’ll help attendees understand the landscape for pediatric drug development.

Attendees will 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  • Fully comply with FDA’s recent draft guidance on iPSPs, including when an iPSP must be submitted and what should be included in an iPSP.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 U.S., E.U., Japan, and Canada.
  • Streamline paperwork on pediatric clinical trials in conjunction with the recently implemented guideline on the application of PIPs.

Register today and understand the regulations manufacturers need to comply with in order to submit pediatric drugs for approval.

Meet the Presenter:
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.

Who Will Benefit:

  • 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

Webinar Details:
Pediatric Clinical Trials Regulation:
Latest FDA and International Compliance Developments
Sept. 7, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/pediatricctreg        

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/pediatricctreg                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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