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MHRA Guidance: Good Clinical Practice (GCP) for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA)Â has released updated guidance on " Good Clinical Practice (GCP)Â for...

Sharan Murugan
Mar 153 min read
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Latest ICH Guidance updates: M15-Model-Informed Drug Development, E6(R3)-Good Clinical Practice: Annex 2, & E11A -Pediatric Extrapolation
The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...

Sharan Murugan
Dec 28, 20242 min read
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Australia's TGA Good Clinical Practice (GCP) Inspection Program
Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...

Sharan Murugan
Nov 3, 20242 min read
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UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...

Sharan Murugan
Jul 23, 20242 min read
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UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...

Sharan Murugan
Apr 9, 20231 min read
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EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...

Sharan Murugan
Sep 1, 20221 min read
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Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...

Sharan Murugan
Jun 26, 20211 min read
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