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May 7, 20232 min read

EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS

Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...

Feb 2, 20231 min read

Ireland's HPRA: Guide to Clinical Trial Applications

Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial...

Aug 3, 20211 min read

Clinical Trials Information System (CTIS) to go-live in 6 Months – EMA

The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for...

Jul 25, 20211 min read

Clinical Trials Information System (CTIS) Free Webinar – EMA

Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the...