The 61st AFI Symposium was held from 8 to 10 June 2022, which, as usual, took place at the Rimini Palacongressi. The 12 scientific sessions touched upon the most diverse topics: from clinical research to technological innovation, from APIs to supplements, from regulatory affairs to quality, from drugs to medical devices.

We went to follow the session of Thursday 9 reserved for pharmacovigilance for you. Here’s what they talked about.

Pharmacovigilance: from the Risk Minimization Plan to information material

The title of this year’s Symposium was “The Pharmaceutical World: the paradigms of a new era”, therefore the sessions could only turn on the return to normality. For pharmacovigilance, one of the most challenging activities now is the implementation of the “additional Risk Minimization Measures – aRMM”. The session therefore dealt with the risk minimization activity in all its aspects, from the point of view of all the stakeholders involved: the pharmaceutical company, the authority, the healthcare worker and the patient.

After an introduction by dr. Oliva di Mylan, who dedicated the session to the memory of Dr. Pimpinella, manager of the AIFA Pharmacovigilance Office, recently deceased, to speak was Dr. Cagnato of DOC Generici who explained how the Risk Management Plan activity is carried out by the pharmaceutical company, immediately followed by dr. Diana of AIFA who instead exposed the approach of the Regulatory Authority.

To evaluate the point of view of the pharmaceutical company with respect to that of the patient, there was an interesting double interview held by Veronica Franchina of A.O. Papardo, who asked questions about the importance of the information material respectively to Dr. Pappalardo of AUSL Romagna and to Dr. Patrucco di Sofar and experienced patient Eupati.

At the end, a round table, to which in addition to the aforementioned participants of the session, was added Dr. Pescatore of Farmindustria, where all the exponents of the various sectors were able to discuss the issues of the individual interventions and answer questions from the public.