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Professional after sale service, As an IT professional, RAC-US Examcollection Dumps it has become extremely important to have certifications in your resume.NEW QUESTION 51
According to ICH, which of the following components of study information is NOT required in a clinical study report?- A. Detailed CV of all investigators
- B. Protocol and protocol amendments
- C. Randomization scheme and codes
- D. List of lECs or lRBs
Answer: A
NEW QUESTION 52
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?- A. "Has the product been approved for mor&4nan 10 years?"
- B. "Is the product better than currently available alternatives?"
- C. "Is the product an established gold standard?"
- D. "Is the product profitable for the manufacturer?"
Answer: B
NEW QUESTION 53
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?- A. Three years after the last clinical study site was supplied with investigational drugs
- B. For at least two years after the last approval of an application in an ICH region
- C. Until the product has been discontinued from marketing in all ICH regions
- D. For a minimum of 10 years after completion of the clinical study
Answer: B
NEW QUESTION 54
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?- A. Follow-up meeting after submission
- B. Frequent communication
- C. Documented agreement
- D. Early collaboration
Answer: B
NEW QUESTION 55
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?- A. Prepare the international monograph change submission first and then prepare the local change when required.
- B. Analyze the impact of the international monograph change on the local pharmacopeia.
- C. Transfer the notice of the upcoming international monograph change to QA for further processing.
- D. Confirm that the international monograph change is not related to local pharmacopeia.
Answer: C
NEW QUESTION 56
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