The EU Clinical Trial Regulation has come into force on 31 January 2022. Although primarily aiming at making the EU a more attractive place for clinical research by facilitating and speeding up the approval process in multi-national trials, many national changes to authorisation and supervision of mono-national clinical trials are now applicable. The CTA application process including the structure of the CTA dossier is now identical in all EU and EEA countries. But the Regulation leaves it up to the Member States to organize the joint dossier assessment by competent authorities and ethics committees. How is this now working in practice in different countries? What is the impact on the review?
COVID has highlighted the importance of Phase 1 trials with vaccines. And yet, only a handful of sponsors, Phase 1 sites and investigators have a thorough understanding of the science, methodology, ethics and logistics required to run such trials. ... New Years EUFEMED webinar will provide you with cutting-edge insight into newest developments around such trials while also learning about the experience of others and providing an opportunity to discuss recommendations.
The third EUFEMED CONFERENCE will be held on 28-30 April 2021 and is entitled: “Exploratory Development of Novel Therapeutic Approaches – Focused strategies based on lessons learned in the pandemic”. The conference provides a unique opportunity to hear about the pandemic experience from regulators, sponsors and those working in CROs. We invite you to join us.