Regardless of the purpose (safety monitoring, due diligence, safety review during clinical development), the evaluation of a signal requires a methodological approach, taking into account data from a variety of sources; e.g. non-clinical, pharmacology, therapeutic class/competitors, clinical data, literature, regulatory databases and RWE data. Particular scrutiny is required during early clinical development, in orphan drug indications, and during product launch.
Holding a post-graduate in pharmacology & pharmaceutical medicine and a diploma in General Internal Medicine, Rudi applies sound medical judgment, ensures a comprehensive and scientifically robust evaluation, communicates clearly, and escalates issues appropriately. His experience covers multiple therapeutic areas and product categories (small molecules, monoclonal antibodies, vaccines, medical devices, OTC products, cosmetics) and he closely interacts with stakeholders.