• EU Marketing Authorization Procedures

    EU Marketing Authorization Procedures

    European Medicines Agency  The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralized marketing authorization applications (MAA’s). A marketing authorization (MA) is the authorization of a medicine to be sold in one, several, or all the European Union’s member states, depending on the type of application that has been submitted and to which agency.

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  • Webinar: Advanced Therapy Conundrum: Should You Build, Outsource, or Go Hybrid?

    Webinar: Advanced Therapy Conundrum: Should You Build, Outsource, or Go Hybrid?

    Webinar: Advanced Therapy Conundrum: Should You Build, Outsource, Or Go Hybrid? June 22, 2021. 2:00PM EST/ 7.00PM GMT Companies developing advanced therapies have to decide early on: Build capacity, and how much? Outsource, and how little? Mix and Match, and how effective? One thing is certain: You need to clearly understand the opportunities and risks

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