Medical Data

  • Read more: Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?
    Article

    Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

    By Timo Minssen In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees…

  • Read more: A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!
    Article

    A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

    By Timo Minssen Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law: “aims to remedy the shortcomings of…