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Conferences and Congresses

As provided for by Legislative Decree no. 219 of 24 April 2006, implementing Directive 2001/83/EC, each pharmaceutical companies intending to organise conferences, congresses or meetings opened to health professionals, either in Italy or in other countries, on topics regarding the use of the medicinal product they manufacture, is bound to apply for a special authorisation to the Italian Medicine Agency (AIFA).

This application should be submitted at least 60 days before the beginning of the event. This is an electronic submission via the AIFA application ACC (Autorizzazione Convegni e Congressi, conferences and congresses authorisation).

Di Renzo Regulatory Affairs has a special unit dedicated to Scientific Information and to the management of conferences and congresses, and can assist companies in the authorisation procedure at the AIFA by performing the following activities:

  • assumption of the role of contact person to access the ACC system and apply for the authorisation to attend conferences and congresses
  • contacts with the organisational secretariats managing the events and with AIFA
  • control of the documentation received in compliance with the regulations in force
  • upload, update and validation of authorisation applications with digital signature
  • payment and self-certification of the AIFA fees via the on line payment (POL) system
  • payment of the stamp duty by self-certification (Presidential decree 28 December 2000, no. 445 art. 46)
  • post-event final statement.