0000000000454728
AUTHOR
Silvia Adami
showing 2 related works from this author
Role of the hospital pharmacist in an Italian antimicrobial stewardship programme
2020
The inappropriate use of antimicrobial agents is contributing to an increasing phenomenon of bacterial resistance. For this reason, there is a growing interest in ‘antimicrobial stewardship’, a series of coordinated and multidisciplinary interventions aimed to promote the safe and appropriate use of antimicrobials in which the pharmacist’s contribution is necessary for the optimal choice of drug, dose, duration of therapy and the implementation of cost containment strategies. AIM OF THE STUDY: We wanted to create a reference model and a specific training manual on antibiotic stewardship to introduce the role of the department pharmacist with specific infection disease skills in the Italian …
The evolution of European Medicines Agency drug approval: the adaptive licensing: Table 1
2015
In March 2014, the European Medicines Agency (EMA) launched a pilot project of ‘adaptive licensing’ to speed up access to drugs in development, in order to respond to unmet medical needs. The project will involve parallel scientific advice from the regulatory agency, pharmaceutical industry, the companies Health Technology Assessment (HTAs) bodies, organisations studying guidelines on clinical treatment and patient associations. The traditional process of drug authorisation is divided into several parts, involving in vitro studies and in vivo studies in animals (preclinical studies), as well as phase 1–3 randomised controlled trials conducted in humans over a predefined period. When authori…