Research Activities

Research Activities (PDF)

Critical appraisal of clinical methodology
Raising awareness about potential biases in clinical research

Critical evaluation of the EU pharmaceutical legislation
Raising awareness among interested parties about the deficiencies of the present EU pharmaceutical legislation and about our proposals to improve it in the public health interest

Development of a Pan-European Infrastructure for clinical trials
Participation in a distributed infrastructure linking national networks of clinical research centres and clinical trials units (ECRIN, European Clinical Research Infrastructure Network) which provides integrated ‘one-stop shop’ services to investigators and sponsors in multinational studies

Critical appraisal of ongoing reforms including pricing reforms in major European countries
Evaluation of ongoing reforms across Europe to enhance generic prescribing rates, drive down generic prices and corresponding originator brands, as well as potential prices of interchangeable brands once standards become available as generics, and the potential for cross cultural learnings to release valuable resources to fund increased volumes and new innovative drugs in the future without prohibitive increases in general taxation or health insurances to continue to provide equitable and comprehensive healthcare in Europe

Development of Pan-European strategies for rational use of drugs
Enhancing rational use in line with an approach that has become known as the ‘five Es’, namely: evaluation; economics; enforcement; education and engineering to further fund increased volumes and new valuable innovative drugs

Development of Pan-European strategies for pharmacovigilance
Developing and testing innovative methods to integrate and present information on benefits and risks in order to provide all stakeholders (patients, prescribers, regulators and pharmaceutical companies) with accurate and useful information on drug-related risks and benefits

Assessment of emerging technologies
Collecting information on emerging medicines with respect to their potential clinical impact and their cost effectiveness and ranking the new products according to their possible marketing authorization date, their potential innovation grade, therapeutic and economic impact, possible price and NHS sustainability with the aim to provide decision makers with timely information on the potential clinical impact and cost effectiveness of new health technologies

Assessment of drug dossiers for regulatory approvals
Expert support to the Rapporteurship for marketing authorisation applications and variations to the conditions of marketing authorisation

Activities for the Technical Scientific Committee at the AIFA
Consultative activities for the Italian Drug Agency regarding regulatory duties with respect to drug quality, safety, efficacy, and cost