News- EIKRA

June 26, 2020 Senior officials from the European Commission (EC – DG SANTE), EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral regulatory dialogue meeting. The collaboration between EMA and FDA formally started in 2003 and the two agencies have now almost daily interactions, most of them structured around working […]

Survey assessing the Member States’ rules on health data in the light of GDPR The European Commission has initiated a study that aims to examine in which manners the processing of personal health date is governed across the EU and how this might affect the cross-border exchange of health data in the EU.The present survey […]

May – June 2020 Edition has been released today! This released edition has a flash news style (read 5-7 min) with info on nomination call for a Committee, leadership changes, a new company member, the IRDiRC Orphan Drug Development Guidebook paper, the recently launched IRDiRC official LinkedIn page, and a short summary of the success […]

June 3, 2020 Dr. Katherine Beaverson has been elected  as new Chair of the IRDiRC Company Constituent Committee (CCC), she is the Patient Advocacy Director for the Rare Disease Research Unit at Pfizer.  The IRDiRC CCC brings together representatives from the for-profit pharmaceutical and biotech that work together to identify common bottlenecks to expedite the execution of rare disease research in the company […]

June 3, 2020 IRDiRC welcomes Illumina Inc. as new member to its Company Constituent Committee, which  brings together representatives from the for-profit pharmaceutical and biotech members of IRDiRC. Illumina is a global leader in genomics and strives to enable clinical laboratories worldwide the ability to offer best-in-class solutions needed to achieve a timely diagnosis and […]