Less than 3 weeks to go to the European Pharmacovigilance Congress 2018, the 2-day event that will take place in Milan on 29th and 30th November 2018, unmissable to clarify any doubts about ICH R3. To understand how to make the most of this opportunity we asked the organizers for some little previews. Here’s how they answered our questions:
1. What did you learn from last year’s edition about the topics of greatest interest to the attendees?
As expected, the matter of greatest interest in this precise historical phase was the new EudraVigilance database as epochal changes on how to exchange data have occurred.
EudraVigilance has become an unavoidable source of data that, compared to the past, must be actively screened by the Pharmaceutical Companies for Signal Detection purposes.
2. Which questions will the participant find answers to?
Compared to the previous year that took into particular consideration the recently implemented EudraVigilance database, this edition aims to provide additional clarification about the actual use of EudraVigilance, also intended as a database for purposes of Signal Detection; to shed light on which information should be imported into the company safety database and to explain the management of duplicates in EudraVigilance.
However, the attention of the 2018 Congress is addressed also to all the other issues about pharmacovigilance. It particularly focuses on those topics that underwent some modifications following the entry into force of the new rules and guidelines of Good Vigilance Practises.
3. In this last period there is much talk of patient support and data safety. What are the interventions on the agenda concerning the protections?
We will talk about the Patient Support Programmes which is a useful tool to provide patients with adequate explanations on how to access medicines.
There will also be interventions on ethics in pharmacovigilance bearing in mind the new European regulation on privacy. Furthermore, the implications that the new regulation will have on pharmacovigilance will be explored.