Klaus Rose, a German MD with postgraduate degrees in General & Pharmaceutical Medicine, was 20 years with Big Pharma. In 2001, he became Global Head Pediatrics at Novartis & 2005 at Roche ; CEO of klausrose Consulting since 2011. He advises on pediatric drug development and FDA/EMA pediatric requirements. Private interests: languages, classical guitar, cooking, wine & gardening

Georg Schmitt obtained his doctoral degree in Zoology and Toxicology at the Ulm University, Germany. He has 27 years of experience in safety assessment and is passionate about pediatric drug development. In his role for nonclinical pediatric support Georg advises project teams on strategies and acts as author/reviewer of regulatory documents. Georg is a member of the expert working group for the ICH S11 guideline (Nonclinical Safety Testing in Support of Development of Pediatric Medicines) and chair of a cross-company ‘Industry Forum for Pediatric Non-Clinical Safety’. He is a Eurotox Registered Toxicologist (ERT) and member of the Swiss Record of Professional Toxicology, the Swiss Society of Toxicology, and the European Teratology Society.

Dr. Ikram Elayan received her B.S. degree in Biology and Biochemistry from Bir Zeit University in Palestine, an M.S. degree in Zoology from Brigham Young University, and a Ph.D. in Pharmacology and Toxicology from the University of Utah. In 2001, Dr. Elayan joined the FDA as a pharmacology/toxicology reviewer and is currently a senior reviewer in the Division of Psychiatry Products.