|
Laboratory's activities
Critical appraisal of clinical methodology
Cooperation to the development and functioning of the pan-European Infrastructure for clinical trials (ECRIN, European Clinical Research Infrastructure Network)
Critical evaluation of the benefit-risk profile of drugs
Assessment of emerging technologies
Optimisation of drug use and healthcare fund stewardship including potential reforms and initiatives to achieve this
Critical appraisal and recommendations for European Pricing and Reimbursement systems including generics, interchangeable products within a class and new innovative medicines
Evaluation of marketing authorization applications submitted to the European or the Italian regulatory agency (respectively, EMA and AIFA) and of subsequent variations
Cooperation to the design and conduct of pharmacovigilance and pharmacoepidemiology studies in Europe
Evaluation of the appropriateness of drug legislation, institutions, and regulatory procedures with respect to public health needs.
Cooperation to the development and to the solution of regulatory issues in developing countries.
|
