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Recorded Webinar
Reducing risk of international drug development by leveraging 2012 FDA/EMA collaboration
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
The major agencies are exchanging practices in quality, nonclinical and clinical development and , reviews/assessment of MAA/NDAs with a view to learning to more efficiently approve new medicines and reduce any pharmacovigilance risk. Aspects of the cooperation which started in 2003 will be shared and its acceleration during 2010-2012. Special interactive "clusters" have been established to facilitate exchange.
So how will all this help a pharmaceutical company with their product development, or can it deter this? What is the overall impact?
The presentation will cover the following areas:
- The begginings of EMA/FDA collaboration
- Parallel scientific advice
- Orphan drugs
- Paediatric programmes
- GMP and GCP
- Clinical development e.g. oncology drugs, advances therapies, biosimilars
- Others
Who should attend
Anyone who is interested in drug development
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