医学资料外教gcp.pptVIP

GCP: The Global Standard for Clinical Research Audrey F. Jakubowski, Ph. D. Visiting Professor PUMCH November 29,1999 Outline Abbreviations to remember Background rush to develop new drugs need clinical quality standards Origins of Good Clinical Practices (GCP) Content of the ICH GCP Guideline (1997) Global implementation of GCP Glossary of relevant terms Abbreviations to remember GCP Good Clinical Practices ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use IRB Institutional Review Board IEC Independent