Title: EMA Policy 0070 Real Life Experience – Voydeya

Presenters: Raquel Billiones, PhD and Alison McIntosh, PhD for the CORE Reference Team 

Please click here to register.

The next CORE Reference webinar will focus on preparing an EMA Policy 0070 Anonymisation Report (AnR), using examples from the Voydeya submission completed in Spring 2024 and with clinical data published on 26 June 2024. Members of the CORE Reference team will discuss specific challenges presented by rare diseases, including selection of appropriate anonymisation methods and will outline some of the problems challenges this poses with maintaining data utility. The webinar will also cover interactions with the EMA and present some  lessons learned from the Voydeya anonymisation process.

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).