Recent changes to the EU Clinical Trials Regulation has prompted to Onorach Launch 2 new eLearning courses which explain how to gain authorisation and conduct clinical research under the new rules. If you are a Regulatory affairs or Healthcare professional or are involved in clinical development these 2 courses are designed for you.
The European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the European Economic Area (EEA). It establishes a harmonised procedure for gaining and maintaining authorisation for trials on the basis of a single electronic application per trial, and subsequent interactions, via a single EU online information system. Member states concerned in a trial (MSCs) collaborate on, and coordinate, its evaluation and supervision. The Regulation also mandates greater transparency of information on trials. The Regulation applies from 31 January 2022 and, after a grace period of one year, sponsors of all new clinical trials in the EEA must comply with it.
Onorach are happy to announce that they are launching 2 new eLearning Courses which cover the critical aspects of the new rules. The first course focuses on Gaining Authorisation for clinical trials and the second course focuses on Conducting Clinical Trials.
CT11: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation.
This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.
This course is 2 hours in length and is at an Introductory/Intermediate level.
All BioDundee members can enjoy a 10% discount on this and all Onorach eLearning courses by using code BIODUNDEE10.
CT12: How to Conduct Clinical Research Under the EU Clinical Trials Regulation
This course describes the requirements that must be met by, and options available to, the sponsor during the conduct of an authorised clinical trial. It identifies the various interactions with MSCs that occur via the Clinical Trials Information System (CTIS), and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT11 sets out the European legal and regulatory context for clinical trials and describes how to apply via the CTIS for authorisation to conduct trials. The two courses therefore provide an ideal foundation for understanding and complying with the new law.
This course is 1 hour in length and is at an Introductory/Intermediate level.
All BioDundee members can enjoy a 10% discount on this and all Onorach eLearning courses by using code BIODUNDEE10.
Visit https://www.onorach.com/eLearning.htm to view all Onorach’s elearning courses.