Date to be announced
Contact us for more infoTRAINING TIMES
Regulatory expectations for paediatric trials (EMA, FDA)
Practical implementation of regulatory expectations
Understand the specific requirements of the paediatric population
Tools for generating data in paediatric patients
How to design a paediatric study
Overcome the challenges of paediatric patient recruitment
How to interact with regulatory bodies (Perspectives of a long time EMA and AGES assessor)
Understand requirements to address unmet therapeutic/diagnostic needs
Discuss how to overcome paediatric complexities, including scientific, legal, ethical and regulatory
(Formerly a Clinical Assessor at the Austrian Agency for Health and Food Safety and the European Medicines Agency)
Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching, medical practice. Between 2007 – 2023 he worked at the Austrian Medicines & Medical Devices Agency (scientific office) and was a member of the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency (EMA) for 15 years. Currently Dr Huemer is now regulatory and scientific consultant.
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