Monday, 30 January 2023

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.

NPEU - The Chancellor Masters of Scholars of the University of Oxford

The University of Oxford is a civil corporation established under common law, which was formally incorporated by the Act for Incorporation of Both Universities 1571 under the name of 'The Chancellor Masters and Scholars of the University of Oxford', but is more commonly referred to as the University of Oxford or Oxford University. PENTA has a long history of collaboration with this institution, from the organization of online training courses to ad hoc specialized consultancies (e.g statistical revision of clinical protocols, data anlyses, revision of clinical study reports). In NeoVanc, NPEU will provide support for the Statistical Analysis tasks.

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). These centres are major stakeholders for the development and implementation of the project through making their resources available to the NeoVanc Consortium, while not carrying out any part of the project independently. The Third Party provides the resources (medical staff, nurses, etc. i.e. human resources) to secure patient enrollment, 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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