The coming into force of the new European Regulation 536/2014 on Clinical Trials of Medicinal products, scheduled for October 2018, is focusing on the attention of all professionals involved in the clinical research process.
The new regulation brings substantial and important changes to the way clinical trials are carried out and the relationships between Sponsors, Ethics Committees, Regulatory Agencies and Researchers.
Regulation 536/2014 (Clinical Trial Regulation) will bring industry professionals to a completely renewed scenario that will probably require an adaptation of both operation and structures.
The aim of the new legislation is to streamline the bureaucratic aspects through a simple authorization process, which involves centralizing the procedure with a homogeneous framework in all Member States. Administrative management of clinical trials should also be simpler through the use of a new EU portal.
Other important novelties include low-level clinical trials, compensation for damage (with a risk-proportionate approach), co-sponsorship, new information on informed consent, the fitness of experimental sites, experiments in vulnerable populations and in emergencies, the new opportunities for greater transparency and information on clinical trials, the role of ECs, the certification for independent research.
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