Enrolement will be open from 19th July to 27th Sept 2023.
Title of Course: Registries in Paediatric Drug Development: Opportunities & Challenges
Edition of the course: Pilot Edition
Course Duration: 3-4 hours
Course start date: 4th Sept 2023
Course end date: 30th Oct 2023
Course enrollment: Enrollment is open from 19th July to 27th Sept 2023
To enrol in this course, please contact your National Hub who will supply you with the course password.
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.
This course will explain how registry data can be used within all phases of paediatric clinical trials, the ethical and legal aspects of using registry data and how regulatory level data can be generated.
The course is a mixture of pre-recorded lectures and a final live interactive webinar. The webinar is a unique opportunity to discuss all of the challenges and opportunities raised during the lectures and provides learners the opportunity to interact directly with registry experts.
This course will consist of 6 pre-recorded lectures (approx. 20 minutes each in duration) and a live webinar (between 1-2 hours) to be held on the 4th October. The purpose of the webinar is for learners to interact with the teachers and discuss topics raised in the lectures. Learners are encouraged to watch all pre-recorded lectures in advance of the webinar.
The programme of lectures includes:
1. Introduction to registries
2. Structure and contents of clinical registries (includes Pharmachild case study)
3. Types of use of registry data for clinical trial programmes in paediatrics
4. Ethico-legal aspects of registry data-re-use for commercial purposes.
5. Practical aspects of using national registries in pharmacovigilance and paediatric drug development (includes ECFS case study)
6. How to generate and share regulatory-level research data: the EMA Guidance document
Who is the course for?
The course will be aimed at personnel involved in clinical trials, including but not limited to PIs, researchers, clinicians, clinical trial coordinators, research nurses etc.
Max. number of persons that each national hub can enrol: Unrestricted
Bloom’s taxonomy level of the course:
On completion of the course and a short multiple choice quiz you will receive a certificate of completion.