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.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule1 day