Consulting Services for ATMP Denmark Program

This contract opportunity is a re-tender of the previous sub-agreement for consulting services related to the ATMP Denmark program. The initial tender was canceled because the received bids did not meet the actual needs of Amgros. This tender involves awarding a framework agreement for consulting assistance in conducting national and international assessments and analyses of regulatory, organizational, and structural aspects related to the development and implementation of Advanced Therapy Medicinal Products (ATMP). The framework agreement includes support for qualitative data collection and analysis, as well as evaluations concerning regulatory, structural, and organizational issues surrounding innovative medicines, including ATMP, in both Danish and international contexts. Tasks will include identifying, analyzing, and describing key regulatory challenges and potential solutions, informed by international experiences. The international analysis will also highlight organizational experiences from other countries that may be relevant for a Danish model for ATMP. Potential solutions may involve simplifying structures, collaboration models, processes, and tools such as guidelines and communication tools that can be pilot tested. The supplier will also be responsible for data collection tasks, including literature searches in relevant Danish and foreign literature, existing relevant work, and similar assessments, as well as conducting qualitative data collection through expert interviews, focus group interviews, and workshops, including participant recruitment. The framework agreement will also cover mapping available ATMP expertise and specific competencies in the field, as well as experiences with the development of academic ATMPs. Ongoing needs for various mapping tasks are expected. The purpose of the framework agreement is to provide and disseminate knowledge that can contribute to strengthening the development, testing, and implementation of commercial and academic advanced therapies in Denmark. Consultants will work closely with Amgros in a project group, coordinating tasks and contributing their expertise where knowledge gathering and deliverable development are needed. The framework agreement has been awarded to one supplier.