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Tag Archives: clinical data

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

1.            Introduction The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data electronically by investigator site staff at the point of care. In its opinion, EMA’s Committee for Medicinal Products for Human Use (CHMP) does

EMA’s new guidance on publication of clinical data

On 3 February 2016 European Medicines Agency (“EMA’s”) introduced new External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use(“the New External Guidance”).

European Court invalidates transfer of clinical data from the EU to the U.S through the Safe Harbor Framework

The Court of Justice of the European Union declares invalid the European Commission’s Safe Harbor Decision and its implications on the transfer of clinical data to the U.S On 6 October 2015, the Court of Justice of the European Union (“CJEU”) ruled that the European Commission Decision on the adequacy of the EU-U.S Safe Harbor

Update on the Implementation of the EMA Disclosure Policy on Publication of Clinical Data

On 24 June 2015, the European Medicines Agency (“EMA”) delivered an update on the implementation of its policy concerning the publication of clinical data. It is recalled that the EMA Disclosure Policy concerning the publication of clinical data was adopted on 2 October 2014. The EMA Disclosure Policy could enable access by interested third parties