ICH E6 (R3) introduces a dedicated section on data governance, reflecting the increasing complexity of data sources and systems used in modern trials. Sponsors are expected to maintain oversight of ...
High-Tech Revamp: FDA Announces New Measures for Clinical Trials, Invites Feedback on GCP Guidelines
FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft ...
The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical ...
This workshop investigates the meaning of Good Clinical Practice (GCP), where it is applicable, and how it differs from other regulations governing clinical research. The focus is on aspects of GCP ...
Unless the norms of Good Clinical Practices in India are harmonized with International Council of Harmonization (ICH), Indian companies would find it difficult to cope with demands of future global ...
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