For National Competent Authorities, IDMP implementation is not an option and is already legally compulsory for pharmacovigilance. Industry has already started to submit data in the IDMP format for CAP products variation forms and this will soon be extended to all other forms.
NCAs need thus to :
During this event, we intend to cover the following (non-exhaustive) questions:
The IDMP journey requires a lot of (new) competencies, and we believe that a representation of both IT and Business would be very much beneficial.
The information collected prior and during the meeting will also help the project to formulate important recommendations to key actors such as the European Commission, EMA, the Global IDMP Working Group and the Standards Development organisations. It might also provide the rationale for a new project proposal which could be discussed with the EU Commission.
Where will the event take place?
The event will conveniently take place in the historic city of Ghent, Belgium which is less than one hour by train from the main Belgian airport.
Participants to the UNICOM meeting on November 28TH are also warmly invited to attend the UNICOM partner I~HD conference on November 29- Dec 1 where topics of strategic importance for NCAs such as the use of real-world evidence or patient safety will be the central focus. Several strategic initiatives and projects will be present to exchange their experience with the I~HD and UNICOM communities.