From 7th to 9th June 2017 took place the 57th edition af AFI Symposium. Here are ten aspects raised during the seminars.

This year too, at the conference centre of Rimini, took place the AFI Symposium. From 7th to 9th June the excellences concerned with the pharmaceutical world, are gathered for the 57th edition of the event, having as subject “Present and future of the pharmaceutical sector: problems and solutions”.

And in the next future of the pharmaceutical sector, there is the introduction of new rules ICH R3, a theme of great interest for the pharmaceutical companies that have to align to them to correctly carry out the pharmacovigilance.

This topic was discussed during the XI session, on Friday afternoon, entitled “Which future for pharmacovigilance in the pharmaceutical companies?

We were in the conference room and for those who would have liked to be present, we extracted ten aspects raised during the seminar:

  1. The RNF-AIFA, the Italian pharmacovigilance authority, will not be decommissioned
    Dr. Anna Rosa Marra – RNF-AIFA
  2. The current process of sending cases to pharmaceutical companies and to EMA will be maintained by RNF-AIFA
    Dr. Anna Rosa Marra – RNF-AIFA
  3. Due to a delay in the information development, RNF-AIFA will continue to transmit electronically Adverse Events to EMA using the XML format
    Dr. Anna Rosa Marra – RNF-AIFA
  4. The Pharmacovigilance Risk Assessment Committee (PRAC) settled down for 2017 the achievement of ambitious goals, including optimizing the managing of the adverse events reporting, strengthening the international collaborations, to treat the reports sent by Market Authorisation Holders (MAHs) after the go-live of the new database, to supply the international database WHO-UMC (Uppsala Monitoring Centre) with Adverse Events, to define the guidelines for pharmacovigilance related to Special Populations (people who might be more sensitive to exposure to hazardous substances because of factors such as age, sex, behavioral disorders and pathologies)
    Amelia Cupelli – RNF-AIFA
  5. Some European countries developed apps for smartphones, for private use, for adverse events transmission to Authorities.
    For example in the UK it is called YellowCard, in the Netherlands there is Lareb, in Croatia there is Halmed
    Amelia Cupelli – RNF-AIFA
  6. EMA, that receives the ICSR(s) from the MAH and sends them to the National Competent Authorities (NCA) of reference, will have to manage the data increase coming from the new obligations, including the transmission of the Not Serious cases
    Cristina de Irala – AEFI
  7. MAHs have no longer provided ICSR to NCA, but exclusively to EudraVigilance (European Union Drugs Regulatory Authorities database)
    Cristina de Irala – AEFI
  8. The QPPV is a resource to be re-evaluated. It is the person that studies the drug behavior in the real life, since clinical trials not always highlight each casuistry. Its function in the company is an opportunity, that helps to find the risk/benefit ratio, as integrant part of the development, enrichment and knowledge of the product.
    Paolo Biffignandi and Enrico Magni – AFI
  9. It is important that the QPPV is internal to the company to contribute to protecting the economic investment, the credibility and the exposition to the inspective and legal risks
    Paolo Biffignandi and Enrico Magni – AFI
  10. In the company each employee, regardless of his role, might become aware of an adverse event. For this reason, it is important that each one receives adequate training about pharmacovigilance
    Andrea Oliva – Borhringer Ingelheim

From this conference, in which national and international experts spoke, we have drawn three final conclusions:

  • Stands out a mismatch and an incongruity, between Italy and Europe: while in Italy the national authority will continue to send the Adverse Events to EMA, abroad is the MAH that accomplishes this task, without intermediaries
  • It is evident a lack of awareness of the pharmacovigilance value, that it is considered a cost and not an opportunity of growth for all pharmaceutical companies
  • Thankfully there are excellent realities which philosophy strives for aligning all team members to a unique sensibility about the drugs’ safety.