Regulatory Affairs Office

The performed duties support  researchers in maintaining high standards of research integrity, quality and  ethics in compliance with national and international laws, regulations and  policies.

Activities

  • Support  for researchers in the development of the study protocol and the feasibility  assessment.
  • Submission  of the Dossier to the Competent Authorities and Ethics Committees for the  application for the required authorization to conduct the study and  subsequent amendments.
  • Updating  and filing of essential trial documentation.
  • Management  of external Sponsor contacts.
  • Support  for researchers in establishing relationships with funders of  sponsor-initiated trials (initial communications, review of the agreements,  investigational drug supply and updates during the trial).
  • Organization  and integration of secure and legally compliant data collection processes.
  • Establishment  and coordination of Clinical Trials Review Commitees.
  • Arrangement  of events for the dissemination of research results and continuous education  of researchers.
Head Unit
No items found.
Staff
Michela
Crotti
Researcher
michela.crotti@marionegri.it
Simone
Amaglio
Researcher
simone.amaglio@marionegri.it

Tieniti aggiornato sulle novità dell'Istituto Mario Negri. 

Iscriviti alla newsletter
Pagina Italiano