Center for health regulatory policies

The Centre is responsible for the critical evaluation of clinical research methodology, pharmaceutical legislation and policies with a view to raising awareness among the scientific community and the public about potential constraints and distortions in drug decision-making, to propose solutions aligning rules with public health needs. The activity is also focused on the promotion of independent clinical research through participation in the development and implementation of a European infrastructure to support the planning and conduct of clinical trials.

Main Projects

Drug regulatory processes

- Analysis of off-label use of medicines and international regulations (in collaboration with the World Health Organization).

- Critical assessment of evaluation criteria and processes adopted by the regulatory authorities, innovation of new drugs, transparency of clinical trials and regulatory processes, including the publication of documents and data submitted by the pharmaceutical companies to obtain the marketing authorization.

Clinical research methodology and promotion of independent research

- The PERsonalised MedicIne Trials (‘PERMIT’) project on methodological standards for personalised medicine research (H2020 project,

- Promotion of independent clinical research through the participation in the European Clinical Research Infrastructure Network (ECRIN, and network CRIGH (The Clinical Research Initiative for Global Health,

- Planning and conduction of educational programs on clinical trial and evidence syntheses methodology.

Rational use of biologic drugs

- Analysis of clinical evidence on switch between originators and biosimilars

- Development of novel laboratory approaches to optimize the clinical efficacy and safety of biological medicines and their biosimilars (in collaboration with the Laboratory of Pharmacodynamics and Pharmacokinetics of the Mario Negri Institute) 

Clinical research and decision-making processes

- Clinical trials on prophylactic surgery plus HIPEC with CO2 in patients affected by colorectal carcinoma and gastric carcinoma (in collaboration with the Laboratory of Clinical Trials of the Mario Negri Institute).

- Planning and conduction of evidence syntheses and HTA reports in the field of surgery.

- Planning and conduction of HTA report on the assessment of carrier status of cystic fibrosis.

Senior Advisor

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