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 will 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.
The UNICOM partners will meet on November 28TH but NCAs which are not members of the consortium are invited to join us on the 29th . All participants are also warmly invited to attend the UNICOM partners EHTEL and I~HD conferences 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.
Here is a short decsrition of the global event:
The Digital Health and Data Week is a three-day event, the result of the collaboration between EHTEL, I~HD, and the UNICOM project consortium. They are partnering to work on digital health solutions and data that result in the provision of real value for care and research. All three days of the week include complementary topics, and their content builds on each other.
Today, it has never been so important for all digital health stakeholders to network and learn from each other’s experiences.
In order to make it worth your time and effort to come in person to Ghent, i~HD, EHTEL, and UNICOM, are partnering together to create a unique Digital Health and Data Week. All three organisations are collaborating in organising a combined set of events during the last week of November 2023, in Ghent (Belgium).
All three days of the week include complementary topics, and their content builds on each other.