Wednesday, 16 August 2017

Third Parties & Subcontractors

GISF - Italian Group for Pharmacoeconomics Studies

It is an association born in 1999 with the aim of collecting and comparing different pharmacoeconomic experiences in order to identify a common European strategy. In the years, the GISF has consolidated its mission especially aimed at optimisating the Drug R&D and Regulatory processes, ultimately resulting in a better and prompt availability of novel drugs and improved therapies for various diseases (mainly orphan and paediatric conditions). Currently, GISF offers regulatory and scientific consultancy services to support drug R&D for pharmaceutical and biotechnological companies and for regulatory authorities. The services offered ranges from regulatory consultancy for the writing, preparation and submission of registration dossiers to Regulatory Authorities, to the management of the submission of Clinical Trial documentation to Ethics Committee during the whole process and also to the pre- and post-marketing socioeconomic evaluations, in accordance with the initial GISF mission. During the last years GISF has developed in-depth regulatory expertise in the field of paediatric medicines, especially in the planning, drafting and management of paediatric development plan. Indeed, GISF has contributed to the preparation, submission and follow up of several Paediatric Investigation Plans (PIPs), including those related to two EC funded projects aimed at developing off patent products in the paediatric population, i.e. Neomero (meropenem) and DEEP (deferirprone).
GISF cooperates with numerous paediatric networks such as TEDDYNoe, Ospedale Pediatrico Bambino Gesù, PENTA, Neomero and DEEP consortia. GISF also set up a database on medicinal products authorised in Europe, both through the Centralised and Decentralised Procedure, for the use in the paediatric population.
GISF contribution will be addressed to ensure the compliance of the project with the EU legislative and regulatory requirements necessary to develop a medicinal product in the context of the EU Paediatric Regulation, i.e. ultimately leading to the PUMA granting for vancomycin.

Fundación para la Investigación Biomédica

Fundación para la Investigación Biomédica del Hospital 12 de Octubre is the third party linked to Hospital 12 de Octubre. Collaboration between SERMAS (Hospital) and Fundación is carried through a prior collaboration agreement, by means of which the latter handles the financial and administrative aspects of the Hospital’s involvement in research projects, including all issues relating to the employment and payment of additional personnel, purchase of equipment and consumables, etc. The Foundation is located in the premises of the Hospital.

NeoNatal Intensive Care Units - NICUs

The nature of the NeoVanc collaboration implies the involvement of Neonatal Intensive Care Units (NICUs) which are not internal to the partner institutions to which they are affiliated but belong to other legal entities (third parties, see table 6). These centres are major stakeholders for the development and implementation of the project through making their resources available to NeoVanc while not carrying out any part of NeoVanc work independently. Third Party Agreements are established between each participant and their corresponding third parties. These agreements state clearly what is expected from the third party and refer to the estimated costs for the third party while placing responsibility on the beneficiary for the follow-up and control of the work being carried out. The third party will provide the resources (medical staff, nurses, etc. i.e. human resources) to secure patient enrolment, treatment and follow-up in each study.

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This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no: 602041
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