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UK MHRA Guidance: Clinical Trials Regulations Enforcement Provisions
This guidance , " Clinical Trials Regulations enforcement provisions , " explains how regulatory authorities enforce compliance in clinical trials. Its primary focus is to ensure that trials are conducted in a way that protects participant safety, rights, and data integrity. It supports the implementation of the Medicines for Human Use (Clinical Trials) Regulations, ensuring that all trials meet required legal and ethical standards. Purpose of Enforcement Provisions The purp
Sharan Murugan
Mar 212 min read
UK MHRA Guidance: How to Notify a Clinical Investigation for a Medical Device & CTR Signed to Law
Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and...
Sharan Murugan
Apr 18, 20253 min read
EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...
Sharan Murugan
Jul 24, 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...
Sharan Murugan
May 7, 20232 min read
Guide to Clinical Trials conducted under the CTR in Ireland
Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...
Sharan Murugan
May 8, 20221 min read
Guidance for Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
On 3-February, 2022 Ireland adopted a new guideline the "EU Clinical Trial Regulation" (Regulation No 536/2014, hereafter ‘CTR’), was...
Sharan Murugan
Feb 6, 20221 min read