The Biopharmaceuticals, Biosimilars and Advanced Therapies 2014 is focused on
- 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
- Immunogenicity
- Comparability
- Bioassays, combination products
- Adventitious safety
- Comparability
- ATMPs
- Bioassays
- Immunogenicity
- Quality by design
- Adventitious agents
- Combination products
The Biopharmaceuticals, Biosimilars and Advanced Therapies 2014 is intended for:
- Early stage drug developers
- Regulatory affairs and clinical research professionals
- Practising physicians and pharmacists
