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UK MHRA Guidance: Clinical Trials for Medicines: Good Clinical Practice Inspections
Good clinical practice (GCP) is an ethical and scientific quality guideline concerning the design, conduct, analysis and reporting of clinical trials of medicines. The Clinical trials for medicines: Good clinical practice inspections guidance provides information on GCP compliance, inspection processes, inspection findings, corrective actions and post-inspection activities. Compliance with Good Clinical Practice Organisations involved in clinical trials are required to comply
Sharan Murugan
Sep 265 min read
EMA Guideline: Good Pharmacovigilance Practices (GVP): Module III on Pharmacovigilance Inspections
Effective pharmacovigilance is essential for protecting patients and supporting the safe and effective use of medicinal products. The Guidelines on Good Pharmacovigilance Practices (GVP) provide a framework for pharmacovigilance activities in the European Union. The latest introductory cover note announces the publication of Revision 2 of Module III on Pharmacovigilance Inspections, reflecting recent changes to the applicable European pharmacovigilance legislation. Background
Sharan Murugan
Sep 133 min read
EMA Guidance: XEVPRM – Electronic Submission of Medicinal Product Information
Accurate and structured medicinal product information is an important part of the regulatory and pharmacovigilance framework. Chapter 3.II: XEVPRM Detailed User Guidance provides detailed instructions for marketing authorisation holders (MAHs) on the electronic submission of information on medicinal products for human use to the European Medicines Agency through the XEVMPD. What is XEVPRM? XEVPRM stands for eXtended EudraVigilance Medicinal Product Report Message. It is the m
Sharan Murugan
Sep 133 min read