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 German e-Pharma day 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.

Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. The new ICH GCP Guidance Integrated Addendum (March 2018) provides a unified standard to facilitate the mutual acceptance of data from clinical trials.