Biosimilars FORUM
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10 years of the regulatory framework in Europe This conference gives you a thorough update on the challenges arising in connection with the revised biosimilars guideline and addresses comparability exercises, bioequivalence, interchangeability and immunogenicity testing.50.10814 8.66164
| Wann |
08.07.2015 um 09:00 bis 09.07.2015 um 17:00 |
|---|---|
| Veranstaltungsort | Steigenberger Metropolitan |
| Stadt | Frankfurt |
| Kontaktname | Dr. Henriette Wolf-Klein |
| Kontakttelefon | 0621/500 680 |
| Zielgruppe |
This conference addresses the needs of managers in the pharmaceutical industry who work with biosimilars. Especially those working in the following areas will benefit from this event: - marketing authorisation - clinical & preclinical trials - quality & analytics - business development & law. |
| Termin übernehmen |
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Aims and objectives:
We would like to give you a thorough update on the new challenges and opportunities arising in connection with the revised overarching biosimilars guideline and the updated product-specific guidelines.
During the two-day conference you will receive valuable information on comparability exercises, bioequivalence, interchangeability and immunogenicity testing, as well as in-depth information on quality issues.
After having attended this meeting you will be familiar with the current regulatory requirements and will have a first insight into the global trends. You will know about the main development challenges and will have new ideas on how to overcome them (e.g. in designing appropriate studies and analysing programmes).
Topics:
- Effective and feasible biosimilar clinical programmes
- Clinical immunogenicity testing
- CMC/quality risk management
- Comparability exercise
- Smart extrapolation and interchangeability
- Global trends
Weitere Informationen über diesen Termin…
FORUM Institut für Management GmbH
Programm
1507235.pdf
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PDF document,
218 kB (223,515 bytes)
