The Course on BioPharmaceuticals and Advanced Therapies is part of the PhD Programme in Pharmaceutical Sciences, and provides an overview of both classical and biotechnology derived medicinal products and on the pathways used for scientific advice, clinical trials and marketing authorizations in Europe. The course will also cover in detail the particular requirements for the CMC section, comparability packages and important safety procedures. The particular aspects of the non-clinical and clinical development of biopharmaceuticals will be presented. Case studies discussing how to develop proteins or cell therapies, such as monoclonal antibodies will illustrate the approach taken to identify benefit/risk ratio. A detailed presentation of the specific considerations for the development of biosimilar medicinal products, will be given during the course. The training program welcomes the participation of external academic and scientific community members.
Case-studies will be inserted for the practical application of knowledge gained. The training will be delivered as presentations on individual topics, interspersed by case studies and conclude with an outlook on further developments in this fast moving field.
The course intends to improve PhD students’ knowledge in the discovery of potential biotherapeutics, the improvement of production and monitoring of drugs and the translation of these drugs to the clinics.