Karl Heinz brings a wealth of expertise in regulatory strategy, particularly in neuroscience, ophthalmology, pediatric drug development, orphan products, and in various therapeutic areas.
He actively engages with the academic and professional community, making notable contributions to conferences and workshops (e.g. RAPS Conventions in the US and EU) online courses in clinical trial planning and pediatric medicine.
Leveraging his extensive experience in medical and biological research and regulation, he also teaches at the Vienna University of Applied Sciences.
Key Areas Of Expertise
- Extensive expertise in regulatory strategy, especially in neuroscience, ophthalmology, paediatric drug development, orphan products, and various other therapeutic areas.
- Proficient in conducting scientific advice procedures, paediatric investigation plans, and marketing authorization assessments with the EMA.
- Involved in approximately 300 scientific advice procedures and 400 paediatric investigation plans, showcasing a broad expertise across many therapeutic areas.
- Active contribution to regulatory assessments and scientific evaluations as an Austrian Delegate and member of CHMP Scientific Advice Working Party (SAWP) and Paediatric Committee (PDCO) at the European Medicines Agency.
- Expert in the following Therapeutic Areas: Neuroscience, Ophthalmology, Paediatric Drug Development, Rare Diseases, Toxicology, Metabolic Diseases, Dermatology, Otolaryngology & Parasitology
Before NDA
Karl-Heinz has an extensive professional background. Most recently, he served as a Freelance Consultant with KHH consult Vienna, providing invaluable medical and regulatory expertise.
Karl-Heinz studied both medicine and biology. Working for over 20 years as a physiologist at the Medical University of Vienna (research and teaching). After completing his MD he continued his medical specialisation (Facharzt) also in physiology with internships in clinical pharmacology and ophthalmology, while also being member of the ethics committee at the Medical University of Vienna.
In 2007 he became clinical assessor at the Austrian Medicines & Medical Devices Agency, soon also appointed as delegate in both the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency for about 14 years.
Recent Publications
Contributed chapters to the following books:
K.-H. Huemer: The Pediatric Regulation. in Fundamentals of EU Regulatory Affairs, 8th edition (Sen ed. P.A.Jones) Rockville 2017
K.-H. Huemer: Paediatric Regulation and the Paediatric Investigation Plan-EU. In Global Pediatric Development of Drugs, Biologics, and Medical Devices (ed. J.Jennings, L.McBride), Rockville 2021
