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More information7th October 2021
On behalf of the HMA-EMA joint Big Data Steering Group we are pleased to announce two upcoming stakeholder events.
On 30 November 2021, the Agency will host a webinar on Learnings Initiative for Optimal Use of Big Data.
The objectives of this workshop include to:
· review lessons learned from submissions of real-world data in regulatory applications and discuss future perspectives for big data submission;
· discuss challenges of using innovative methods in the use of big data for regulatory purpose;
· discuss mechanisms for stakeholders’ input on future developments.
On 7 December 2021, the 2nd EU Big Data Stakeholder Forum will take place.
The objectives of this Forum include to:
· inform on current achievements and future plans;
· listen to stakeholders’ views;
· discuss areas for collaboration.
Both events will be held as virtual meetings. To enable wide participation, the events will be broadcast and a recording made public. We anticipate space for a broad representation of stakeholders, and attendance will be organised through EU associations and by direct invitations.
The registration process and the outlines of the agendas’ will be available shortly.
For related information please refer to:
HMA/EMA Big Data Steering Group
Big Data Steering Group Workplan 2021-2023
1st EU Big Data Stakeholder Forum
If you are interested in attending as a RQA representative, please email Anthony Wilkinson.