Training Course on Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in Europe
4-6 May 2011 | Basel, Switzerland
This 3-day training course focuses on the highly important contribution of biopharmaceuticals to new drug candidates. As the function of biopharmaceuticals is fully explored and utilised, they will become increasingly relevant to the drug development community.
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.
Key Topics
· 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
Download [PDF] programme | Register online
Drug Information Association
Elisabethenanlage 25, Postfach
4002 Basel, Switzerland
+41 61 225 51 36 (tel) | +41 61 225 51 52 (fax) | www.diahome.org
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