FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP).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 ...

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 ...

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 ...

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 ...