In the Regulatory Session you will receive an update on the implementation of the EU Clinical Trials Directive 536/2014 with a focus on guidelines under consultation, various pilot programmes in the Member States, the EU Portal as well as the new transparency rules, which will change our research environment tremendously. Other regulatory topics will bring you up-to-date on Medical Devices and Paediatric Clinical Trials, both topics undergoing lots of changes in the past and in the near future. Furthermore, the ICH-GCP Addendum will be first-hand presented in the final form thus setting the stage for a whole session on Risk-based Quality Management.

Another focus will be IoT – Internet of Things. It is certainly high time to familiarise yourself with Cloud Solutions and eHealth Clinical Research but also the impact of the Internet on delivering treatments is a fascinating topic.

Non-interventional studies gain importance and the lack of harmonisation in this area does not make it easy when international studies are designed. Adaptive Pathways and Market Access are topics which need to be understood, otherwise the new treatments will not be available to patients in the way they should be - fast and safe.

Finally, the session on patient-centric approach will familiarise us with Personalised Medicine, the just recently accepted Data Privacy Shield between the EU and the USA and the benefit to use the huge data amounts which are already available in order to gain knowledge on diseases and treatments.

The 3rd EUCROF Conference takes place in beautiful Prague, an event and a city you must not miss!

For more information on the conference and to register, please click here.