European Commission

Exco InTouch receives privacy shield framework self-certification

Tuesday, January 17, 2017

ERT company Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has formally received EU-U.S. Privacy Shield Framework Self-Certification status by the U.S. Department of Commerce’s International Trade Administration (ITA). The designation certifies that Exco InTouch’s practices meet or exceed the data privacy and security principles outlined by U.S. Department of Commerce and European Commission.

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The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

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EMA to revise first-in-human clinical trials guideline

Friday, November 18, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.

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