by Syneos Health_1 | 25 Jun, 2019 | EU Clinical Trials Regulation, GDPR, Uncategorized
The European Commission Directorate General for Health has published a question and answer document that aims to explain the interplay between the Clinical Trials Regulation (EU) 536/2014 and the General Data Protection Regulation (EU) 2016/679. This document “will be...
by chuck_ltd | 22 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News
Regulation 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (the “Regulation”) Introduction Traditionally, the results of clinical trials have not always been published. This is often due to an increased number of...
by chuck_ltd | 19 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News
Delivery Time Frame for the EU Portal and EU Database October 2018 – Regulation (EU) No 536/2014 becomes applicable October 2021 – Directive on Clinical Trials 2001/20/EC no longer applicable These are planned timelines. They have been set out to deliver...
by chuck_ltd | 5 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials
Overview of comments on EMA/641479/2014 Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014” Draft proposal for an addendum, on transparency, to the “Functional...
