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EMA Policy 0070 Real Life Experience – Voydeya

12:30 - 13:45 CET This webinar will provide a brief overview of the Policy 0070 AnR and associated anonymisation methodology. Outline challenges presented by rare diseases as illustrated by the Voydeya submission. Outline challenges posed in maintaining data utility.  Review interactions with EMA including the pre-submission meeting. Discuss challenges and learnings from the Voydeya anonymisation process.  Previous related presentation: The CORE Reference webinar on 7 June 2024 included a general introduction to the Policy 0070 Anonymisation Report (AnR) Template. For details, see https://www.core-reference.org/media/1088/core-reference-seminar-emwa-valencia-may-2024-and-webinar-07-june-2024-slides.pdf (refer to webinar slides 21 – 37 or presentation video at 30 – 58 minutes).
When
04/12/2024 11:30 - 12:45

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