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It is announced that the Scientific Information Office, having taken note of the various reports received from Associations of pharmaceutical companies and from individual companies and considered the reasons presented to be valid - also in the light of the indications already provided by the Office itself with the Questions and Answers documents published in the years 2013 and 2016 - considered it appropriate to proceed with a punctual update of the User Manual.
The update of the Company Role User Manual Ver. 2.1 dated 06/20/2019 concerns the clarification of the obligation to fill in the "Communications" field (now on page 39), the revision of the paragraph "2.4.4 Acquisition of Modify MP”, with the addition of two new initial periods to replace the first previous one (now on page 40), and the elimination of the forecast contained in the parenthesis that closed the last period on page 40. 42 of the previous version.
The current version, attached here, is identified as the "Company Role User Manual version 2.1.1 dated 07/02/2020" and, shortly, will be made downloadable directly from the IMS System - Medical Scientific Information present on the Front-End.
PDF Company Role User Manual (version 2.1.1 dated 07/02/2020) [6.39 Mb] >
This document is intended to illustrate how Pharmaceutical Companies compile the form for the transmission of data on scientific representatives and their activities to the AIFA Scientific Information Office, in compliance with the provisions of paragraph 1 of articles 122 "Requirements and activities of scientific representatives" and 126 "Scientific Service" of Legislative Decree 219/2006.
Filling in the "form" on the Front End replaces to all intents and purposes sending it according to the methods previously envisaged and in force until 2017; the new functionalities of the "IMS - Medical Scientific Information" application made available on the AIFA Portal allow, thanks to the Front End application, the sending and archiving of data in digital mode.
The Scientific Information Office is responsible for verifying and monitoring the Promotional Materials deposited with AIFA by Pharmaceutical Companies, in compliance with the provisions of Legislative Decree 219/2006 regarding Medical-Scientific Information.
Scientific Information Office
Cynthia Berghella
infomedicoscientifica@aifa.gov.it