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RAC Devices Exam Prep 2024 Questions and Answers Correct
RAC Devices Exam Prep 2024 Questions and Answers Correct 
Who is the European Medicines Agency (EMA) - Answer ️️ -an agency of the European Union 
(EU) in charge of the evaluation and supervision of medicinal products. The primary reason for 
establishing EMA was to harmonise the work being done by the individual 
regulatory bodies in Europe. 
Relevance of EMA in EU - Answer ️️ -founded in 1995, working across the EU to protect 
human and animal health by assessing medicines to rigorous ...
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- Exam (elaborations)
- • 6 pages •
RAC Devices Exam Prep 2024 Questions and Answers Correct 
Who is the European Medicines Agency (EMA) - Answer ️️ -an agency of the European Union 
(EU) in charge of the evaluation and supervision of medicinal products. The primary reason for 
establishing EMA was to harmonise the work being done by the individual 
regulatory bodies in Europe. 
Relevance of EMA in EU - Answer ️️ -founded in 1995, working across the EU to protect 
human and animal health by assessing medicines to rigorous ...
RAC Practice Exam 1 Latest 2024 with complete solution
RAC Practice Exam 1 Latest 2024 with 
complete solution 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic records. 
D Est...
- Package deal
- Exam (elaborations)
- • 22 pages •
RAC Practice Exam 1 Latest 2024 with 
complete solution 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic records. 
D Est...
RAC Exam New Edition 2024 Solved Correctly
RAC Exam New Edition 2024 Solved Correctly 
drug - Answer ️️ -Any article intended for use in the diagnosis, cure, mitigation, treatment or 
prevention of disease in man. 
medical device - Answer ️️ -An instrument, apparatus, implement, machine, contrivance, 
implant, in vitro reagent or similar or relate article, including any component, part or accessory 
intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, 
treatment or prevention of disease on...
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- Exam (elaborations)
- • 23 pages •
RAC Exam New Edition 2024 Solved Correctly 
drug - Answer ️️ -Any article intended for use in the diagnosis, cure, mitigation, treatment or 
prevention of disease in man. 
medical device - Answer ️️ -An instrument, apparatus, implement, machine, contrivance, 
implant, in vitro reagent or similar or relate article, including any component, part or accessory 
intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, 
treatment or prevention of disease on...
RAC Practice Exam 1 Questions and Answers New Version 2024 Complete
RAC Practice Exam 1 Questions and Answers 
New Version 2024 Complete 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic re...
- Package deal
- Exam (elaborations)
- • 22 pages •
RAC Practice Exam 1 Questions and Answers 
New Version 2024 Complete 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic re...
RAC Prep Medical Devices Exam Prep 2024 with complete solution
RAC Prep Medical Devices Exam Prep 
2024 with complete solution 
device - Answer ️️ -instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent or related article: 
-recognized by NF-USP 
-intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment 
or prevention of disease 
-intended to affect the structure or function of the body 
-not achieving any primary purpose through chemical action 
-not dependent on metabolism for prima...
- Package deal
- Exam (elaborations)
- • 16 pages •
RAC Prep Medical Devices Exam Prep 
2024 with complete solution 
device - Answer ️️ -instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent or related article: 
-recognized by NF-USP 
-intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment 
or prevention of disease 
-intended to affect the structure or function of the body 
-not achieving any primary purpose through chemical action 
-not dependent on metabolism for prima...
US RAC Review Questions and Answers RAPS Modules 2024 with complete solution
US RAC Review Questions and Answers RAPS 
Modules 2024 with complete solution 
In which situation is an IND not required? 
A) You intend to conduct a clinical trial with an investigational new drug 
B) You intend to conduct a clinical trial with an approved drug to support a marketing 
application for a new indication 
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic 
information 
D) You intend to conduct a clinical trial using 2 of your approved dru...
- Package deal
- Exam (elaborations)
- • 29 pages •
US RAC Review Questions and Answers RAPS 
Modules 2024 with complete solution 
In which situation is an IND not required? 
A) You intend to conduct a clinical trial with an investigational new drug 
B) You intend to conduct a clinical trial with an approved drug to support a marketing 
application for a new indication 
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic 
information 
D) You intend to conduct a clinical trial using 2 of your approved dru...
US RAC Review Questions RAPS Modules 2024 with complete solution
US RAC Review Questions RAPS Modules 
2024 with complete solution 
In which situation is an IND not required? 
A) You intend to conduct a clinical trial with an investigational new drug 
B) You intend to conduct a clinical trial with an approved drug to support a marketing 
application for a new indication 
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic 
information 
D) You intend to conduct a clinical trial using 2 of your approved drugs in a new ...
- Package deal
- Exam (elaborations)
- • 29 pages •
US RAC Review Questions RAPS Modules 
2024 with complete solution 
In which situation is an IND not required? 
A) You intend to conduct a clinical trial with an investigational new drug 
B) You intend to conduct a clinical trial with an approved drug to support a marketing 
application for a new indication 
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic 
information 
D) You intend to conduct a clinical trial using 2 of your approved drugs in a new ...
RAC Exam practice test bank 2024 all possible questions and answers with complete solution
RAC Exam practice test bank 2024 all 
possible questions and answers with 
complete solution 
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 
1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe 
tolerances for unavoidable poisonous substances(1:1) - Answer ️️ -A: Proof of efficacy 
Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham- 
Humphrey Amendments b) Hatch-Waxman Act c) Cont...
- Package deal
- Exam (elaborations)
- • 19 pages •
RAC Exam practice test bank 2024 all 
possible questions and answers with 
complete solution 
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 
1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe 
tolerances for unavoidable poisonous substances(1:1) - Answer ️️ -A: Proof of efficacy 
Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham- 
Humphrey Amendments b) Hatch-Waxman Act c) Cont...
DEVICE RAC 2024 Questions and Answers Graded A(Actual test)
DEVICE RAC 2024 Questions and 
Answers Graded A(Actual test) 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on 
primary mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - Answer ️️ -C 
A company wants to modify its legally marketed device such that the modification does not 
affect the intended use or alter the fundamental scientific technology of the device. If the design 
outputs of the modified device meet the design input requirements, th...
- Package deal
- Exam (elaborations)
- • 21 pages •
DEVICE RAC 2024 Questions and 
Answers Graded A(Actual test) 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on 
primary mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - Answer ️️ -C 
A company wants to modify its legally marketed device such that the modification does not 
affect the intended use or alter the fundamental scientific technology of the device. If the design 
outputs of the modified device meet the design input requirements, th...
DEVICE RAC EXAM QUESTIONS AND ANSWERS 2024 WITH COMPLETE SOLUTION
DEVICE RAC EXAM QUESTIONS AND 
ANSWERS 2024 WITH COMPLETE 
SOLUTION 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on 
primary mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - Answer ️️ -C 
A company wants to modify its legally marketed device such that the modification does not 
affect the intended use or alter the fundamental scientific technology of the device. If the design 
outputs of the modified device meet the design input requireme...
- Package deal
- Exam (elaborations)
- • 21 pages •
DEVICE RAC EXAM QUESTIONS AND 
ANSWERS 2024 WITH COMPLETE 
SOLUTION 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on 
primary mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - Answer ️️ -C 
A company wants to modify its legally marketed device such that the modification does not 
affect the intended use or alter the fundamental scientific technology of the device. If the design 
outputs of the modified device meet the design input requireme...
INSY-3303 FINAL EXAM STUDY GUIDE WITH COMPLETE SOLUTIONS
the answers are incorrect
Product Owner/ Product Manager(POPM) SAFe Agile Exam Questions and Answers
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