Pharmacovigilance - Guides d'étude, Notes de cours & Résumés

RAC Drugs Final Exam 2024 | 40 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ (EU) MA - Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - National, centralised, mutual recognition, decentralized procedures MAH - A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - Active substance...

RAC DRUGS LATEST 2023 ALREADY PASSED (EU) MA Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA National, centralised, mutual recognition, decentralized procedures MAH A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? Active substance international non-proprietary name, trade name. SmPC Summary of Product Char...

Monitoring, reporting and prevention of adverse effects with pharmaceutical products is most closely related to: a. pharmacoeconomics b. Pharmacotherapeutics c. pharmacoepidemiology d. pharmacovigilance Correct Answer-pharmacovigilance Let us say a patient happens to ingest an extended-release form of calcium channel blocker, which therapy may be appropriate within 1-6 hours post-ingestion?

US RAC Practice Exam 2016 Test Bank Questions and Answers All Correct (Verified Answers) According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record. B: Device master record. C. Complaint files. D. Design history file. - Explanation: A. This contains the dates of manufactured, the quantity manufactured, the quantity released for distribution, control numbers used and the ...

RAC DRUGS Combined Tests Questions with 100% Revised Correct Answers | Verified | Latest Update | Graded A+ (EU) MA meaning and valid for how long - ANSWER : Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - ANSWER : National, centralised, mutual recognition, decentralized procedures MAH - ANSWER : A legal person or legal entity who must be established in the European Economic Area comp...

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...

Which of the following medications are known as selective serotonin re-uptake inhibitors (SSRIs)? i. Nortriptyline ii. Citalopram iii. Duloxetine iv. Fluoxetine v. Venlafaxine vi. • Question 3 Which disease state of a non-adherent patient is at greater risk for substance use, violence, and victimization as well as worse overall quality of life? Schizophrenia Response Feedback: “Moreover, non-adherent patients with schizophrenia are at greater risk for substance use, violence, ...

BCMAS Study Questions and Answers (Graded A)BCMAS Study Questions and Answers (Graded A)BCMAS Study Questions and Answers (Graded A)BCMAS Study Questions and Answers (Graded A) What role of Medical Affairs is responsible for documenting and reporting adverse events, side effects, and safety issues? - ANSWER-Pharmacovigilance Many of the origins of the pharmaceutical industry originated in what country? - ANSWER-Germany Which of the following are part of the SMART paradigm for medical affa...

(EU) MA - Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - National, centralised, mutual recognition, decentralized procedures MAH - A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - Active substance international non-proprietary name, trade name. SmPC - Summary of Product Characteristics PIL - Produ...

(EU) MA - Answer-Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - Answer-National, centralised, mutual recognition, decentralized procedures MAH - Answer-A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - Answer-Active substance international non-proprietary name, trade name. SmPC - Answer-Summary of P...