Research support for ATMP

Support and advice from the ATMP Center

Coordination

We coordinate the initial activities needed to conduct research trials with ATMP. This includes liaising with prioritization boards and initial coordination of the parties to be involved in the trial. This applies to both academic and industry-sponsored trials.

Support on regulatory issues

The ATMP Center provides support on regulatory issues specific to the ATMP area, such as with the GMO/GMM regulatory framework. We also help with administering contracts and legal issues specific to the ATMP area to ensure that clinical trials with ATMPs are conducted in accordance with current legislation.

Project support

The ATMP Center offers start-up support for the elements specific to an ATMP trial. For example, it provides direct support to the investigator and the clinic before the start of the trial. In cases where the medicinal product is received and stored via the region's own pharmacy function, a specific agreement may be needed and the ATMP Center and the Region Skåne Hospital Pharmacy will assist with the type of documentation needed.

Quality assurance

The ATMP Center works to quality assure all ATMP trials in the region. This means e.g., that we, in collaboration with the Region Skåne Hospital Pharmacy , help to produce specific documentation and instructions for the handling of medicinal product. We also support with the documentation needed to conduct a First in Human (FiH) trial of an ATMP investigational medicinal product.

Other research support

For those parts of a trial that are more general and do not require specific ATMP support, Clinical Studies Sweden - Forum Söder offers a wide range of research support and advice to researchers and research staff in all professions in the Southern healthcare region.

Contact us

The ATMP Center is a gateway for industry, academia, and investigators seeking assistance and support in implementing ATMP in clinical trials. Contact us at atmp-centrum@skane.se.