FDA, EMA and other regulatory agencies routinely perform both announced and unannounced phase I clinical investigator inspections, in order to verify the accuracy and reliability of data that has been submitted to the agency, and to provide real-time assessment of the investigator’s conduct of the trial to ensure human safety.
Preparing for a clinical inspection involves making sure that all aspects of your clinical trial are up to code. This includes being able to provide all required documents that prove that your trial is GCP compliant.
A short summary of SGS CPU experience in ensuring site compliance prior to/during an agency inspection, as well as the importance of conducting site internal quality management will be presented.
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Community pharmacists are the health professionals most accessible to the public. They supply medicines in accordance with a prescription or, when legally permitted, sell them without a prescription. In addition to ensuring an accurate supply of appropriate products, their professional activities also cover counselling of patients at the time of dispensing of prescription and non-prescription drugs, drug information to health professionals, patients and the general public, and participation in health-promotion programmes. They maintain links with other health professionals in primary health care.