Work Package 4: Involvement of Patients, HTA and Regulators

Objectives

Developing a Stakeholders and Patient Organizations Forum that offers support to the WPs, in particular to WP2 for developing a Core Outcomes Set for each new indication of HARMONY PLUS;
Streamlining the involvement of patient organizations in the research projects developed by WP2. Keeping them informed about the progress and results in collaboration with WP2;
Developing guidance and decision tools to identify appropriate procedures and resources for regulators and payers in Europe with respect to the research projects of HARMONY PLUS;
Proof of principle project: Identifying an appropriate topic in collaboration with WP2 and WP3, and delivering an early regulatory/Health Technology Assessment scientific advice procedure on the appropriateness of evidence to be used in regulatory and/or reimbursement submission.

Public-private partnership for Big Data in Hematology

HARMONY and HARMONY PLUS are funded through the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding is received from the IMI 2 Joint Undertaking and is listed under grant agreement for HARMONY No. 116026 and grant agreement for HARMONY PLUS No. 945406. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).