国际期刊数据库有那些.ppt

Selection Criteria: Safety issues Bioequivalence issues and Special situations Timeliness reports Direct reports vs. Mandatory reports Completeness reports Getting Ready for an Inspection Review previous establishment inspection reports Review information provided with the assignment,which may include 3500A forms, currentapproved labeling and AERS-generated ADE lists Review applicable CFR sections, ComplianceProgram Information, and FDA guidelines Contact the staff member who initiated yourassignment All of the firm’s written procedures that describe receipt, evaluation, and submissions of ADEs during the time period under investigation. Organizational charts showing which persons were  or are responsible for all compliant handling during  the time period under investigation. All written procedures describing who is responsible for changing complaint handling procedures during the time period under investigation. All correspondence, meeting minutes, and documents relating to all ADEs. List of all the company’s drug products and approval dates. Package inserts for products covered under the inspection. A listing of all ADE complaints received over a specific timeframe, such as 2 years, including foreign and domestic events. Periodic reports, specific 3500A forms, and associated raw data. Lists of collection sites, processing centers, and reporting units. Copies of all contractual agreements related to collection, evaluation and reporting ADEs. Section Four How to Conduct an Inspection * Field Investigators:ADE Detectives 学分网 Section One Introduction to the Team and Their Roles FDA’s Postmarketing Adverse Drug Experience Inspectional Program …”promote and protect public health by assuring that safe and effective drugs are available to Americans.” …”provide pharmacovigilance resources to the Center for Drug Evaluation and Research to ensure the safety of marketed drugs.” Field Investigations Office of Drug Safety