In the context of the preparation of the implementation of the Clinical Trials Regulation (CTR), which will come into force on 31 January 2022, a specific webinar for SMEs and academic sponsors on key aspects of the CTR and the new processes via the Clinical Trials Information System (CTIS) for clinical trial application submissions will be organised on 29 November 2021. The CTIS highlights of October 2021 are available on the European Medicines Agency (EMA) website.
In addition, the next FAMHP info session will be organised in December 2021. The confirmation of the date and modalities for participation will be provided in November 2021 by means of a news published on the FAMHP website.
Training support information
A whole set of training modules has been prepared by the EMA and is available on the EMA’s website. Module 19 has been specifically prepared for training of SMEs and academic sponsors.
Additional guidance to help clinical trial sponsors (pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors) prepare for using CTIS can be found in the Sponsor handbook which covers priority topics identified with the help of clinical trial sponsors, with reference and links to further supporting materials.
The EMA will be updating this CTIS sponsor handbook with further priority topics as needed.