July 2020

1 - EMA Biannual Newsletter – 'CTIS Highlights'

EMA’s Clinical Trial Information System (CTIS) – currently under development - will be the single-entry point for submitting, assessing, authorising, supervising and reporting a clinical trial in all Member States of the EU. The planned 'go live' date is December 2021. To promote understanding of CTIS progress, EMA have started publishing a biannual Newsletter called 'CTIS Highlights'. Read the first issue (June 2020) here.

2 - FDANEWS Webinar on Transparency and Privacy

Are you prepared for the shift to increased clinical trial transparency and the drive for more access to data?

CORE Reference author, Vivian Fagan is co-presenting with her IQVIA colleague, Sarah Lyons a Webinar titled 'Pharmaceutical Clinical Trials Transparency and Privacy. Build Brand Trust and Navigate Evolving Regulations’ on Thursday 23 July 2020, 11.00 – 12.30 EDT. Register here.

3 - Fact sheet on MDR requirements for Transparency and Public Information

This Fact Sheet indicates the information which will be made available to the public in Eudamed and outside Eudamed, respectively from the entry into application of the MDR (May 2021) and the release of Eudamed (planned for May 2022).

4 - Clinical investigation of medical devices for human subjects — Good clinical practice

The long-awaited update to the GCP standards for medical device trials, ISO 14155:2020, is released on 29 July 2020. The previous version was from 2011.

This has been closely aligned to the ICH E6 GCP guidance for pharma, including clear requirements for transparency for device trials.

The catch is that while ICH guidance docs are available for free, ISO standard documents have to be purchased.