News

AIFA - European Assessment Office

Scope

The following Rules of Procedure should be considered every time an Applicant/ Marketing Authorisation Holder (MAH) requires a meeting with AIFA representatives - as CHMP members - for  pre-submission meetings, presentation of pipelines, scientific advice etc.

Request to MAHs concerning information on medicinal products for human use containing phtalates as excipients.

The meeting saw the participation, including AIFA, of the representatives of Agencies of the following European countries: Austria, Finland, France, Hungary, Ireland, Italy, Lithuania, Malta, Norway, Poland, Portugal, Spain, Switzerland, the Netherlands and United Kingdom and such as Representatives of European Commission and EMA.

The Italian Medicines Agency is also participating this year, for the third time, at the annual meeting organized by the Drug Information Association – the international meeting organized by the Drug Information Association - the international network that bring together  more than 18,000 professionals in the pharmaceutical industry - which will be held on June 19-23  in Chicago.
The DIA Annual Meeting is an event designed to the exchange and updating of content areas related to scientific research, regulatory, risk management, HTA and all aspects that revolve around the drug life cycle in a 'perspective of international comparison can help to define new models and strategies, scenarios and calibrated to changing contexts.
AIFA participation in the event this year is particularly prestigious: in addition to the exhibition, there are different working sessions with the participation of Agency speakers.

The Italian Medicines Agency (AIFA) was visited on 23-26 May by a team of European assessors for a benchmarking visit within the framework of the BEMA II (Benchmarking of the European Medicines Agencies) initiative. The European assessors appreciated the spirit of openness and transparency with which the staff of AIFA presented their systems and procedures, and underlined the passion and commitment to improving the processes of the Agency, which underwent a deep reaching reorganisation under the leadership of its Director-General, Prof. Guido Rasi.