Rome, March 18. (Adnkronos Salute) – Archives with the names of the doctors visited by the scientific representatives of the drug 'in order'. This is what 9 pharmaceutical companies have already ascertained in the first months of 2014, thanks to the official certificate that Pharmasoft FeA is able to issue following the 'green light' obtained from Accredia, the only recognized body in Italy, which operates under the supervision by the Ministry of Economic Development, to certify that third-party bodies or certification and inspection bodies have the skills to assess the conformity of products, processes and systems with the reference standards. To talk about the future of this topic, also in light of the new European regulation on privacy which should be approved by the end of the year, the round table 'Pharmaceutical archives: from risk assessment to certification, new opportunities for optimizing management was held today in Rome binding bureaucracy. Within the framework of the obligations set out in articles 119 and 122 of Legislative Decree 219/06, pharmaceutical companies must annually notify the Italian Medicines Agency (Aifa) by 31 January of each year of the number of doctors visited on a regional basis, also following many visit distribution parameters. The aim is to apply the rule in the best possible way, but for some time now we have been talking about the results which are often not very reliable, since they are numbers entered on a fiduciary basis. Furthermore, many Regions did not accept the provisions of the regulation on controls because they declared that they did not have the ability to carry out the controls, and that they would have involved a disproportionate cost. For their part, companies find themselves having to spend large amounts of time and money to carry out what is required by the control bodies.
Drugs: Lorenzin, guaranteeing the truthfulness of data on doctors visited by companies
Rome, March 18. – (Adnkronos Salute) – "It is necessary to guarantee the truthfulness of the communications that pharmaceutical organizations are called upon to send annually to the control authorities on the number of doctors visited". This was highlighted by the Minister of Health, Beatrice Lorenzin, in a message sent on the occasion of the round table 'Pharmaceutical archives: from risk assessment to certification', organized in Rome by Pharmasoft Fea. The ministry, writes Lorenzin, intends to reserve "attention to such an important issue, in a particularly delicate moment for the country, in which bureaucracy continues to have a high weight in the life of the state and citizens and coinciding with the approval in first reading by the European Parliament of the new privacy regulation".
