Bristows LLP

Drawing the boundaries of data disclosure in clinical trials

22 February 2017 | By Grant Strachan (Bristows LLP), Maria Isabel Manley (Bristows LLP)

In the context of clinical trial data disclosure, since 2010 the regulatory impetus has shifted towards enhanced disclosure obligations, culminating in the publication of a ‘pro-active’ policy on the publication of clinical trial data for medicinal products for human use1 (Policy 0070) by the European Medicines Agency (EMA) in October…

article

The legal framework applicable to biosimilars in the EU

24 August 2016 | By Hilary Jones (Bristows LLP)

Biosimilars are becoming increasingly important in the European Union’s biopharmaceutical landscape due to the increased growth of biologicals as key therapies and the financial pressure this puts on healthcare budgets.

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Drawing the boundaries of data disclosure in clinical trials

The legal framework applicable to biosimilars in the EU