The Aspects of Clinical Development Related to the ICH E11 Categories of Children

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • March 24, 2014

The presenters will focus on the various considerations related to the ICH E11 defined categories of children (varying from preterm neonates to emancipated adolescents) in clinical development. The speakers will include ethical, study design/scientific and practical issues. They will propose solutions to take these considerations into account and will discuss examples with respect to clinical development.

The aim of this webinar will be to convey the importance of considering differing ages/ stages of development of children when designing and conducting clinical trials, and how doing so can contribute to successful well-designed pediatric studies.


Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research

Dr. Susan P. Tansey, specialty areas include vaccines, cardiovascular, and oncology, although her initial training was in neonatology and pediatric medicine. She has considerable experience in pediatric clinical research and trial design. Dr. Tansey’s expertise in developing detailed clinical development strategies in the pediatric therapeutic field will further strengthen a Premier Research team that brings to the table a wealth of experience in rare disease and pediatric research. Dr. Tansey has considerable international experience in the Pharmaceutical industry, having joined Premier Research from TMC Pharma Services Limited, where she was director of medical services. She previously had held research positions at Pfizer, Wyeth Research, and Servier R&D.

Susanne Schmidt, MD, PhD, Director Medical Affairs, Premier Research

Dr. Susanne Schmidt joined Premier Research in 2012 as a Director Medical Affairs. In this role she provides therapeutic area expertise and oversight as well as medical monitoring support to studies.

Dr. Schmidt is a senior physician, board certified in pediatrics with more than 17 years’ experience in allergy, gastroenterology, bone mineral density and rare disease. Most recently she served as Senior Physician and Research Adviser/Coordinator at Frambu Centre for Rare Disorders in Norway where she was responsible for providing oversight for clinical research projects involving rare diseases. Prior to this she served as Senior Physician, Department of Paediatrics at Borås Central Hospital (Sweden) where she gained valuable insight in several therapeutic areas, such as pediatric gastroenterology, pediatric allergy and diabetes.

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

for pharmaceutical, biotechnology and medical device companies

Xtalks Partners

Premier Research

Premier Research is a leading global contract research organization serving highly innovative biotech, Pharmaceutical and medical technology companies.The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia, neurology, cardiovascular, dermatology, oncology and medical devices.

Premier Research has 24 offices across the globe. It employs over 1,000 clinical professionals. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.

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