Develop "harmonization policies on clinical trials, on populations to be selected for studies, moving towards the integration of the competencies of all European regulatory agencies". And arrive at "a system of homogenization of the parameters with which we all in Europe judge medicines. We must be a single beating heart and this is the direction in which we are going".
This is how Luca Pani, general manager of Aifa, describes the objectives to be pursued on the occasion of the informal meeting organized in Rome between the Pediatric Committee and that for orphan drugs of the EMA. "The two committees that deal with the most important frailties we have at European level, i.e. pediatrics and rare diseases - Pani explained on the sidelines of the meeting - are hosted today in our country as part of a system agreement with which the current EU presidency, which belongs to Cyprus, has asked for help in organizing some meetings.
The main challenges that arise in oncology, hematology, orphan diseases, which therefore affect a very small number of patients and moreover children, will be discussed".
November 23, 2012 – PharmaKronos