Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in Europe

June 6, 2012 6:41 AM

EUCRAF and DIA are organizing the “Authorization of Biopharmaceuticals, Biosimilars and Advance Therapies in Europe” training course in Basel, Switzerland between 17-19 September 2012.

EUCRAF (European Centre for Regulatory Affairs Freiburg) and DIA (Drug Information Association) are organizing this 3-day training course focuses on the highly important contribution of biopharmaceuticals to new  drug development. As the functions of biopharmaceuticals are fully explored and utilised, they will  become increasingly relevant to the drug development community.

The key topics of this training course are:

• Definition and characteristics of biopharmaceuticals
• Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, adventitious safety, bioassay
• Biosimilar medicinal products
• Modules 3, 4 and 5 of the EU CTD of biopharmaceuticals
• Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals

If you are interested, you can reach more information from here:

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