The development of biopharmaceuticals 2015 is a course that covers topics such as:
- Definition and characteristics of biopharmaceuticals
- Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals
- Biosimilar medicinal products
- Modules 3, 4 and 5 of the EU Common Technical Document (CTD) of biopharmaceuticals
- Biopharmaceuticals: immunogenicity, comparability, bioassays, adventitious safety and combination products
The development of biopharmaceuticals 2015 is intended for:
- Early stage drug developers
- Regulatory affairs and clinical research professionals
- Practicing physicians and pharmacists
