This 3-day training course focuses on drug development of biopharmaceuticals which have become the focus of pharmaceutical innovation and currently represent 30% to 50% of newly authorised medicinal products.
Participants will learn about the legislative and regulatory framework for biopharmaceuticals in Europe and the roles of the European Medicines Agency and National Competent Authorities in market access.
This covers the clinical trial stage, licensing and the life-cycle of these products.
Specific development paths will be delineated, such as those for biosimilars and Advanced Therapy Medicinal Products ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.
The scientific basis and data requirements for dossiers at different stages of development will be communicated for the quality, preclinical and clinical parts of regulatory submissions.
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.
Member Industry : 1840
Non-Member Industry : 1970
Member Academia/Charitable/Government/Non-profit (Full-time): 920
Non-Member Academia/Charitable/Government/Non-profit (Full-time): 1050
Speakers: Gabriele Reichmann, Ilona Reischl, Harald Weber
+41 61 225 5151