The introduction of a new medicinal product to the US and European market follows a complex process that may extend many years from the initial discovery through to the FDA and EMA approval and market launch. There are many factors during the product development that impact the success of drug approval and launch, and a thorough understanding of the US and EU regulations and requirements is often underrated. The drug development process is becoming increasingly specialized and the regulatory pathway that works for one program may not work or be applied to another program for the same indication and this also applies to the regions considered.
In this webinar VCLS regulatory science experts analyse the similarities and differences between the US and European health agencies in terms of the review team, meeting opportunities, clinical trial submissions (IND vs. CTA), discuss ways and the right timing to interact with the FDA and EMA and their expedited programs.
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