Division Veterinary Medicine
Assessment of immunological veterinary medicinal products, innovative products and therapies, scientific advice, marketing authorisation and testing, approval of field trials – the Veterinary Medicine division oversees all the regulatory procedures for immunological veterinary medicinal products for pet and domestic animals, farm animals and fish. These regulatory duties are complemented by preliminary and product-related research aimed at the development of new prophylactic and therapeutic approaches for combating zoonoses or economically relevant diseases and innovative concepts for experimental product testing. Experts actively represent the PEI’s Veterinary Medicine division on various committees of the European Medicines Agency (EMA), the Heads of Medicine Agencies (HMA) and the European Directorate for the Quality of Medicines (EDQM), as well as on national committees. The PEI’s Animal Facilities section is also part of the division.
Head of division’s research group
The scientists investigates virus-host interactions in animal (surrogate) models, which also provide insights into the course of a disease in humans. One particular area of focus is the characterisation of the mechanisms of RNA virus biology and pathogenesis. To this end, genetic changes in the pathogens and the resulting effects on the viral life cycle, pathogenesis and immune responses are investigated in order to develop new prophylactic and therapeutic approaches.
Assessment of Immunological Medicinal Products for Veterinary Use section
The section processes and coordinates the marketing authorisation of immunological veterinary medicinal products, assesses the data provided on quality, safety and efficacy, and approves scientific studies for clinical testing (field trials). It oversees more than 410 authorised products throughout their lifecycle, and in 2017/18 handled over 400 follow-up procedures and notifications of variation. In addition, the section plays an active role in drawing up guidelines for immunological veterinary medicinal products and advises on regulatory and scientific issues.
Product Testing of Immunological Medicinal Products for Veterinary Use section
The section tests batches of immunological medicinal products for veterinary use – in 2017/18 there were 4,894 batches in total, of which 1,477 were tested experimentally. This means that the section is Europe’s leading authority in veterinary testing – and can guarantee consistent quality and efficacy. The section conducts research into the replacement of animal testing and the improvement of test methods, and investigates the safety and efficacy of modern viral vector systems for combating infectious diseases and cancers.
Animal Facilities section
The staff breeds, procures and looks after the animals needed at the PEI for experimental batch testing and other experiments, ensures their veterinary care and advises on issues relating to animal testing.
The section investigates strategies for the genetic modification of blood stem cells and blood cells derived from pluripotent stem cells. The group is interested in stem cell self-renewal and differentiation and in the manufacture of blood cells with improved function for therapeutic application.