by Stuart McCully | 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 | 3 Apr, 2017 | 21 Century Cures Act, Cures Act, EU Clinical Trials Regulation, Pragmatic Trials
It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting...
by chuck_ltd | 22 Dec, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News, Publication Guidelines
On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use...
by chuck_ltd | 22 Nov, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News
Note – Amended text in RED Décret n° 2016-1537 du 16 novembre 2016: publication in the French Official Journal of a decree concerning research involving the human person Decree No. 2016-1537 of 16 November 2016, published in the Official Gazette of 17 November...
by chuck_ltd | 24 Feb, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, HTA, News, NIS, Pragmatic Trials, Real Word Evidence, Webinar
Regulators, Health Technology Assessment (HTA) agencies and health care payers are increasingly demanding Real World Evidence (RWE) to support both initial product approval/reimbursement as well as continuing approval/reimbursement over a product’s life cycle....
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 | 21 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
EMA Public Consultation on – ‘Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations’ Start of public consultation: 21 December 2015 Deadline for comments: 31 May 2016 Provide comments using...
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...
