12th SCTO FORUM
On the clinical research horizon: EU CTIS launch and ICH GCP renovation – how will they affect Switzerland?
The EU’s Clinical Trials Regulation (CTR) has been in effect since 2014. Yet its application depends on a functioning platform for the single submission of all clinical trial applications to ethics committees and other authorities, namely the European Clinical Trials Information System (CTIS). The CTIS platform went live on 31 January 2022.
During the SCTO’s annual forum on 26 January 2022, we discussed the EU’s new requirements, their relevance for Switzerland, and what needs to be considered from an academic perspective when submitting applications for clinical trials in Europe. This is particularly relevant when Switzerland is involved in international, multicentre trials.
In addition, the European Medicines Agency (EMA) – one of the founding members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – provided participants with an overview of the vision and objectives of the ongoing, comprehensive renovation of the ICH E6 Good Clinical Practice (GCP) Guideline. During the ensuing discussion session, we considered how this renovation could affect our daily work. Switzerland's Human Research Act requires adherence to the ICH E6 guideline.
Videos of the presentations made at the SCTO’s digital forum and related PDFs are available below.