mAb Biosimilars 2012 - Monoclonal antibodies as biosimilars
- Non-clinical studies for mAb - a risk-based approach
- Clinical trials - clinical endpoints
- Immunogenicity assessment
- Analytical comparison and quality changes
- Preclinical and clinical comparability exercises
The new guideline on similar biological medicinal products containing monoclonal antibodies is expected to be finalised by the end of 2011.
We would like to give you a thorough update on the new challenges and opportunities arising in connection with this guideline, and to discuss with you the preclinical and clinical topics, as well as the quality requirements. Especially the challenging topic of comparability exercises will be addressed in detail.
May we invite you to a firsthand update?
Termin
| Datum: | 01.03.2012 |
| Ort: | InterContinental Wilhelm-Leuschner-Str. 43 -60329 Frankfurt |
| Preis: | 1.490,00 EUR zzgl. MwSt. |
| Link: | http://www.forum-institut.de/fileadmin/pdf/1203235.pdf |
Zielgruppe
This seminar addresses the needs of managers in the pharmaceutical industry. Especially those working in the following areas will benefit from this event: Marketing authorisation, Clinical + preclinical trials, Quality + analytics and Law.
Kontaktinformationen
Weitere Pharma-Seminare - InterContinental,Wilhelm-Leuschner-Str. 43,-60329 Frankfurt
