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 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 new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product. What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?
A. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
B. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
C. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?
A. Conduct a Phase III study for a new unrelated indication of the drug.
B. Develop a generic version of the drug.
C. Develop a better brand-name drug in the same class.
D. Explore litigation strategy for patent infringements on the drug.
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?
A. Expiration date
B. Relevance to regulations
C. Revision history
D. Scope and level of detail
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
A. Systematic procedure to review published scientific journals
B. Systematic procedure to review experiences with the products in use
C. Vigilance procedure to ensure the full traceability of the products
D. Vigilance procedure to notify the regulatory authorities about serious incidents
According to ISO 14971,what is the FIRST step when developing a risk management plan for a medical device?
A. Risk estimation
B. Risk analysis
C. Risk control
D. Risk management
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
A. Deleting an ingredient of the drug product
B. Deleting a drug substance
C. Introducing a new analytical method
D. Strengthening a precaution to the product labeling
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