Скачать с ютуб GCP for Medical Devices: ICH GCP E6 and ISO 14155 Trailer в хорошем качестве

GCP for Medical Devices: ICH GCP E6 and ISO 14155 Trailer

Both ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.