Biosimilar Development Workshop
06.12.2018 12:16
This workshop informs you of recent challenges in biosimilar development programmes with regard to quality, clinical and non-clinical issues.
Termindetails
Wann
27.03.2019
von 09:00 bis 17:00
von 09:00 bis 17:00
Wo
Frankfurt am Main
Kontakttelefon
+49 6221 500-680
Teilnehmer
This workshop addresses the needs of healthcare professionals involved in the development, marketing authorisation and market access of biosimilars.
A working knowledge of biosimilar development is a prerequisite.
A working knowledge of biosimilar development is a prerequisite.
This workshop gives you a thorough update on recent challenges in biosimilar development. Quality, clinical and non-clinical issues will be discussed with reference to recent cases.
It will also provide you with a toolbox for improving your biosimilar development and the ability to position your product.
It will also provide you with a toolbox for improving your biosimilar development and the ability to position your product.
Themen des Seminars:
- Critical quality attributes
- Abbreviated study programme: extrapolating indications
- Similarity testing and interchangeability
- Biobetter elements and cost-saving supplements
- Comparability to pre-change product and originator
- Abbreviated study programme: extrapolating indications
- Similarity testing and interchangeability
- Biobetter elements and cost-saving supplements
- Comparability to pre-change product and originator
