Biopharmaceuticals, Biosimilars and Advanced Therapies 2014

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

Who should Attend

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