Dr. Jana Brajdih Čendak holds the role of QPPV in the company and is also the head of the medical field and pharmacovigilance. She is a physician with extensive knowledge in drug development, clinical trials, and toxicology. Specifically, in the field of toxicology, Jana regularly represents the company with the most important European decision-makers, as she participates as a lecturer in the 3R Working Party and the Nonclinical Working Party at the European Medicines Agency (EMA) every year. She is actively involved in preparing the latest guidelines for preclinical requirements for new drug registration. She is particularly active in the development and use of in silico methods (methods that use mathematical models to predict outcomes based on the chemical structure of a molecule) to assess the toxicity of new active substances and impurities.

Jana can boast very specific knowledge in the field of radiopharmaceuticals, a niche area that has gained new dimensions in recent years. With her experience, she has helped many clients successfully register such active substances, both in Europe and elsewhere in the world, and obtain special drug statuses, such as the orphan status (status of a drug for the treatment of rare diseases).

Jana is also a member of EUCROF (EU CRO Federation), where she actively participates as a lecturer at conferences and has direct contact with decision-makers who shape the latest guidelines for conducting clinical studies (ICH GCP – Good Clinical Practice).