Event German Pharma Day

05 Jun 2019

Zeppelin-Museum Zeppelinheim, Frankfurt, Germany

From Patient-right to data protection: Germany moving forward this is the theme for the 10th German ePharma Day conference.

The legal basis for clinical research is changing rapidly and is driven in Europe and Germany by the EU legislation. On one hand there is the Clinical Trial Regulation EU 536/2014 and its national implementation which are suffering from some delays due to the EU portal, its database and the consequences of BREXIT. On the other hand, there is the more recently General Data Protection Regulation EU 2016/679 (GDPR) and its national implementation (Datenschutz-Grundverordnung, DSGVO), come into force in May 2018, affecting patient rights and data processing. Both legislations are causing to some degree a level of uncertainty.

The conference will examine the consequences of the new regulations from different viewpoints: from patient rights to data protection in clinical research with a special focus on the national adaptations.

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