Working Group 3

Legal and Regulatory Issues

Main Objective

Coordination of harmonisation of legal/regulatory requirements for international trials and other collaborative efforts. From the clinical point of view, high-quality protocols can be performed in the different European countries, however from the legal point of view, each country has to prepare country specific appendices to fulfil the national law request.


a) To harmonise the legal requirements requested from the different European countries with the addition of Switzerland and Norway (all EU countries and non- EU countries within Europe);

b) To develop protocols, agreements, contracts, standard operating procedures (SOPs) and other relevant legal/operational documents related to the network considering all the legal peculiarities of the different countries so that countries specific appendices can be omitted.

For more information, please contact the WG3 Leader

Dr.Olga Tzortzatou on