Biosimilars, Biobetters & Synthetic Scaffold Molecules
12.06.2012 10:57
We would like to give you a thorough update on the new challenges and opportunities arising in connection with the revision of the overarching biosimilar guideline and the upcoming further guidelines/revisions.
We would like 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.
The new FDA follow-on biologics approach will also be covered by the programme.
Termindetails
Wann
21.11.2012 um 09:30 bis
22.11.2012 um 15:00
22.11.2012 um 15:00
Wo
Köln
Kontakttelefon
06221 500-680
Teilnehmer
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.
Topics:
- Biosimilars: non-clinical & clinical aspects
- Biomarker, surrogates etc - minimizing or optimising the study programme?
- Synthetic Scaffold Molecules & "biobetters" - always a stand alone marketing authorisation?
- The new FDA follow-on biologics approach
- Quality changes & comparability exercises according to the CHMP guidance documents
