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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


Apply for this webinar

Who should attend

Anyone who is interested in drug development

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