To develop awareness of ethical and regulatory requirements, and to develop recommendations to facilitate international cooperation.
Description of the work:
The regulatory context of clinical trials differs between countries and world regions. As multinational clinical trials require cross-border cooperation, national regulatory awareness is essential to overcome barriers to innovation and to promote effective international collaboration. Good knowledge of national regulatory systems can also help in trans-national crisis situations or catastrophes (e.g. Ebola outbreak).
This activity will entail an inventory of the legal and statutory foundations governing clinical research in different countries and regions, as well as the identification of differences in regulatory oversight of clinical research between countries/regions. Based on this inventory, methods will be identified to facilitate communication and information sharing on clinical research and regulations among multilateral regulatory authorities.
Moreover, a common repository of information about national laws and regulations for performing clinical trials will be developed, expanding on existing tools.