According to WHO,what are the temperature and humidity conditions for a Zone IVb long- term stability study?
A. 25: C and 60% RH
B. 30?C and 35% RH
C. 30c C and 65% RH
D. 30: C and 75% RH
Which of the following BEST describes the purpose of the ICH?
A. To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions
B. To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions
C. To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions
D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
Company X is planning to acquire the rights for a product marketed by Company Y. As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
A. Intellectual properly
B. Clinical trial data
C. Safety issues
D. Marketing materials
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?
A. Resubmit the entire package.
B. Inform upper management immediately.
C. Contact the legal department and ask them how to proceed.
D. Verify the procedure in the regulation for the corrections.
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
A. Approved indications of the drug
B. Determination of primary mode of action
C. Determination of product design deliverables
D. Guidance documents for the device
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
A. Withdraw the affected product from the markets.
B. Send a "Dear Dr." letter to customers.
C. Notify the global regulatory authorities.
D. Assess the potential safety risk.
Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?
A. Enter into an agreement with Company Y to perform due diligence.
B. Recruit a professional to gather confidential intelligence on Company Y.
C. Request the needed information from the Board of Directors of Company Y.
D. Perform a thorough library search to gather detailed information on Company Y.
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?
A. Add a warning in the IFU.
B. Discontinue the project.
C. Perform another risk-benefit analysis.
D. Redesign the device.
The safety database for an anti-hypertensive drug consists of the following: 461 patients exposed for three months 343 patients exposed for six months 112 patients exposed for nine months 74 patients exposed for 12 months Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
A. 100 patients for 12 months
B. 200 patients for nine months
C. 500 patients for three months
D. 3.000 total patient exposures
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?
A. Recommend an immediate product recall.
B. Compare the approved text with the product label
C. Notify the regulatory authority.
D. Inform the production team.
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