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Sharan Murugan
- Feb 2, 2023
- 1 min
Ireland's HPRA: Guide to Clinical Trial Applications
Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial...
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Sharan Murugan
- Nov 23, 2022
- 1 min
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
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Sharan Murugan
- Sep 4, 2022
- 1 min
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...
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Sharan Murugan
- May 18, 2022
- 1 min
Guidance on Clinical Trial Applications -
The Drug Regulatory Authority of Pakistan (DRAP) published the draft of this guidance document on its website on 8th April 2022 inviting...
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Sharan Murugan
- Dec 11, 2021
- 1 min
Updated Version of Clinical Outcome Assessment Compendium -USFDA
The COA Compendium is part of the FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate...
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Sharan Murugan
- Dec 7, 2021
- 1 min
Regulations & Requirements for Conducting Clinical Trials – SFDA
Saudi Food & Drug Authority released updated guidance on Regulations and Requirements for Conducting Clinical Trials in regards to “Early...
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Sharan Murugan
- Nov 20, 2021
- 1 min
MHRA’s updated Guidance on URGENT SAFETY MEASURE – UK
This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those...
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Sharan Murugan
- Sep 17, 2021
- 1 min
Denmark- Updated Guidance on Implementation Of Decentralised Elements In Clinical Trials
Decentralized clinical trials cover a multitude of elements that reduce, or in some cases even eliminate, the need for the trial...
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Sharan Murugan
- Sep 11, 2021
- 1 min
UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
Managing clinical trials during Coronavirus (COVID-19) On 8th September 2021, MHRA updated the guidance on How investigators and sponsors...
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