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Nov 32 min read

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...

Jul 232 min read

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...

Apr 9, 20231 min read

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...

Sep 1, 20221 min read

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...

Jun 26, 20211 min read

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...