Training Course on Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in Europe

Venue: Basel

Location: Basel, Switzerland

Event Date/Time: May 04, 2011 End Date/Time: May 06, 2011
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The course will provide insight into the data requirements for the Common Technical Dossier (CTD) and the Investigational Medicinal Product Dossier (IMPD) writing.

Case studies on a monocional antibody will illustrate the approach taken the identify the benefit/risk ratio and a case study discussing how to develop a protein, with lack of the relevant animal model, will also be examined. The most essential issues of advanced therapies and biosimilars product classes, which is part of the EU provisions related to biopharmaceuticals, will be outlined in the course.

Featured Topics Include

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

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