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

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.