GCP

EMA Publishes GCP Inspection Coordination Procedure

Clinical sites facing an inspection at the request of the Committee for Medicinal Products for Human Use must sign a letter consenting to the audit and promising to provide all relevant documents, a European Medicines Agency guideline on GCP inspection procedures says. Read More

India Establishes Three-Trial Maximum for Investigators

Investigators participating in clinical trials in India must limit their work to no more than three trials at any given time. That’s one of mandates laid out in 14 finalized regulations issued July 3 by the Central Drugs Standard Control Organization. Read More