The FCT PhD Programme in Medicines and Pharmaceutical Innovation (i3DU; http://www.ff.ul.pt/phd3duul/) trains students in target discovery, drug design, pre-clinical development, and drug safety, bridging the translational gap from discoveries on disease targets and mechanisms into novel diagnostic and therapeutic agents.
The Course on BioPharmaceuticals and Advanced Therapies is part of the PhD Programme in Medicines and Pharmaceutical Innovation (i3DU), 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. An overview will be given on the most essential issues relating to Advanced Therapy Medicinal Products (ATMPs). 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.
The course will be held at the Research Institute for Medicines (iMed.ULisboa), Faculdade de Farmácia, Universidade de Lisboa, in Lisbon, 18-20, 25 and 26 September 2017. The training program is aimed at PhD students, but welcomes the participation of external academic and scientific community members. Registration (https://goo.gl/forms/Ybc0RjLKdO4xPIwA3) is free but mandatory.