TBD, Basel, Switzerland
May 4 2011 9:00AM - May 6 2011 5:00PM
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
- ATMPs
- Biosimilar medicinal products
- Modules 3, 4 and 5 of the EU-CTD of Biopharmaceuticals
Event Code:
11519
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