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.
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 ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.
What You Will Learn
Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals
Definition and characteristics of biopharmaceuticals
Modules 3, 4 and 5 of the EU Common Technical Document (CTD) of biopharmaceuticals
Biosimilar medicinal products
Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, adventitious safety, bioassays, combination products
Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, bioassays, adventitious agents, quality by design, combination products