The Development of Biopharmaceuticals 2017

Topics

• 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

Who should Attend

• Early stage drug developers
• Regulatory affairs and clinical research professionals
• Practicing physicians and pharmacists