Enrolment will be open from 28th Feb 2024 to 27th March 2024
Name of the course: Practical guidance on EU CTR and CTIS
Edition of the course: First Edition
Enrolment Dates: 28th Feb to 27th March 2024 (possible to enrol to each webinar until the day before the webinar)
1st Webinar: 13th March 2024
2nd Webinar: 18th March 2024
3rd Webinar: 28th March 2024
Course duration: 3 hours
To enrol in this course, please contact your National Hubwho will supply you with the course password. Students are invited to enrol in more than 1 webinar if desired.
Your National Hub’s Referent Person for Training and Education will verify your eligibility to enroll to the Course and provide you with the Course’s enrolment password.
Once you receive this Course’s Enrolment Password from your National Hub, please log in on c4c Academy Platform.
If you don’t have an account yet, click on Create new account and follow the instructions.
General Description:
This webinar series “Practical guidance on EU CTR and CTIS” for clinical trials in Europe helps you learn the most crucial information of the EU CTR and its innovations as well as the main preparatory steps to use CTIS portal. You will get practical expert advice starting from the preparation of clinical trial documents for submission, the submission process and its timelines as well as submission of substantial amendments, communication between sponsor, investigators and Member States during the study and notification of study closure. The smooth transition from trials conducted according to the former Directive will be another main topic, enabling you to run the process in the most effective way.
These webinars will look into the main changes introduced in the new EU CTR, the challenges faced with the new regulation as well as the strategy options to overcome them. You will take away the know-how of the EU CTR practice and ease your professional life related to clinical trials.
Programme:
Webinar 1 – 13th March 2024
Clinical Trials Regulation, general principles and new concepts compared to the former Directive 2001/20/EC
Oversight to the Clinical Trials Information System (CTIS)
Webinar 2 – 18th March 2024
The new process for submitting and managing clinical trials information in the EU / EEA
Practical advice on the preparation of documents and interactions regarding the Request for information and answers from sponsor to part I and Part II CT dossier.
The Communication between Sponsor, Investigators and Member States during the study
Webinar 3 – 28th March 2024
Safety reporting in CTIS
Challenges and lessons learned up to now
Who is the course for?
Clinical Project Managers, Principal Investigators, Study Coordinators and persons responsible for dossier submission.
Max. number of persons that each national hub can enrol: Unlimited
There is a minimum number of 10 students to activate the course.
