Biosimilars FORUM
Termindetails
Wann
09.07.2015 um 17:00
Wo
Kontakttelefon
Teilnehmer
Especially those working in the following areas will benefit from this event:
- marketing authorisation
- clinical & preclinical trials
- quality & analytics
- business development & law.
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
