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Sharan Murugan
Jul 24, 20232 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...
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Sharan Murugan
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...
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Sharan Murugan
May 8, 20221 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,...
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Sharan Murugan
Feb 6, 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...
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