Gcp of devices - Study guides, Class notes & Summaries

Resource Hierarchy - Parent/Child Relationship structure - Resembles a file system - Top-down policy inheritance with policy controlled by IAM - Each child object can only have one parent - Org -> Folders (Optional) -> Projects -> Resources Organization - Root node - Organization Admin Role created - Full power to efit any/all resources Notable Organization Roles - Org. Policy Admin: Broad control over all cloud resources - Project Creator: Find-grained control of project cr...

US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed Describe the purpose of a New Drug Application (NDA). The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical in the U.S. What is the purpose of a combination product in regulatory terms? It involves two or more regulated components, such as a drug and device, that work together. Explain what an Orphan Drug Designation provides to a company. It grants incentives lik...

SOCRA CCRP Exam Questions And Answers April 30 1996 - answer-ICH GCP Development Date Quality - answer-ICH Q Efficacy - answer-ICH E Safety - answer-ICH S Multidisciplinary - answer-ICH M guidance for industry, consolidated guideance - answer-ICH E 6 Clinical Safety Data Management Definitions and Standards - answer-ICH E2A Safety pharmacology studies for human pharmaceuticals - answer-ICH S7A Electronic records, electronic signatures - answer-21 CFR ...

April 30 1996 - ANSWERSICH GCP Development Date Quality - ANSWERSICH Q Efficacy - ANSWERSICH E Safety - ANSWERSICH S Multidisciplinary - ANSWERSICH M guidance for industry, consolidated guideance - ANSWERSICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWERSICH E2A Safety pharmacology studies for human pharmaceuticals - ANSWERSICH S7A Electronic records, electronic signatures - ANSWERS21 CFR Part 11 Informed Consent - ANSWERS21 CFR Part 50 Fina...

CCRP SOCRA Exam Graded A+ April 30 1996 - ANSICH GCP Development Date Quality - ANSICH Q Efficacy - ANSICH E Safety - ANSICH S Multidisciplinary - ANSICH M guidance for industry, consolidated guideance - ANSICH E 6 Clinical Safety Data Management Definitions and Standards - ANSICH E2A Safety pharmacology studies for human pharmaceuticals - ANSICH S7A Electronic records, electronic signatures - ANS21 CFR Part 11 Informed Consent - ANS21 CFR Part 50 Financial Disclosures - ANS21 CFR Par...

SOCRA CCRP Exam Questions With 100% Correct Answers. April 30 1996 - correct answer ICH GCP Development Date Quality - correct answer ICH Q Efficacy - correct answer ICH E Safety - correct answer ICH S Multidisciplinary - correct answer ICH M guidance for industry, consolidated guideance - correct answer ICH E 6 Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A Safety pharmacology studies for human pharmaceuticals - correct answer ICH S7A ...

Who is the regulatory authority in the USA? Correct Answer-FDA What are the goals of regulatory authorities? Correct Answer-Protect the public, gather clean data, ensure products are safe and efficacious What are FDA program centers? Correct Answer-CDER, CBER and CDRH What does CDER stand for? Correct Answer-Center for Drug Evaluation and Research What does CBER stand for? Correct Answer-Center for Biologics Evaluation and Research What does CDRH stand for? Correct Answer-Center f...

Laws - passed by national legislative bodies; establish authority of national regulatory body Regulations - Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - "current thinking" of regulatory bodies; non-binding ICH - Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - developed by an organization (sp...

Facility Registration - Devices - within XX days of application or manufacturing - 30 days Facility Re-Registration - Devices, Drugs & Biologics - Annual GLP & GCP Record Retention - 5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Sponsor & IRB - Annual - 60 days from anniversary IND & IDE - time allowed to FDA notification - Beyond which OK to start inves...

April 30 1996 ICH GCP Development Date Quality ICH Q Efficacy ICH E Safety ICH S Multidisciplinary ICH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent 21 CFR Part 50 Financial Disclosures 21 CFR Part 54 Institutional Review Board 21 CFR Part 56 IND Appli...