Gene & Cell therapy/ATMPs in clinical research
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Cell & Gene therapy is a fast-growing field with an increasing number of clinical trials. In order to ensure that reliable data are generated for these very complex and heterogeneous products, well-conducted clinical trials are essential to determine their benefit-risk profile. A number of regulatory guidelines covering the different aspects of investigational ATMPs inform on their drug development requirements.This course will provide the basics of the ATMP clinical development path, from early clinical development to late clinical development. After the course, the different types of ATMPs, their distinctive features compared to IMPs, the impact of the complexity of ATMPs on the clinical development and the regulatory framework.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
Programme highlight
- ATMPs features
- ATMP regulatory framework
- ATMP regulatory procedures
- ATMPs specificities in clinical development
- CTAS´s and IMPDs/INDs
- GMO licenses
- Clinical trial design considerations
Learning objectives
Who should attend
- Anyone who would like to understand the basics of ATMP clinical trials
- Clinical development personnel (scientists, medics) who are involved in the development of clinical protocols for ATMPs
- Clinical operations personnel (clinical trial managers, clinical trial associates) who are involved in the set-up and execution of ATMP trials
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
No trainer yet
No testimonial yet