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NEW QUESTION 37 At a recent scientific meeting, Company Y had two booths: * At one booth, Company Y provided brochures on a completed Phase II study. * In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products. A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

• A. Inform the local regulatory authority of the letter and discuss how to respond.
• B. Inform Company X that it has no right to send such a letter and do nothing further.
• C. Inform the legal department of the letter and discuss how to respond.
• D. Acknowledge receipt of the letter in a written response but do nothing further.

Answer: C   NEW QUESTION 38 A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?

• A. Certificate of Pharmaceutical Product
• B. Certificate of GMP
• C. Certificate of Analysis for the finished product
• D. Certificate of Free Sale

Answer: A   NEW QUESTION 39 According to ICH, which of the following components of study information is NOT required in a clinical study report?

• A. Randomization scheme and codes
• B. Protocol and protocol amendments
• C. Detailed CV of all investigators
• D. List of lECs or lRBs

Answer: C   NEW QUESTION 40 You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

• A. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
• B. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
• C. Advise the senior management to send a "Dear Dr." letter.
• D. No action is required since it is an off-label use.

Answer: B   NEW QUESTION 41 A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

• A. Inform the company's senior management and arrange an emergency meeting
• B. Arrange for additional testing of the product at the testing facility.
• C. Obtain a copy of the proposed regulation and analyze the impact.
• D. Consult with the company's legal department regarding options.

Answer: C   NEW QUESTION 42 ...... DOWNLOAD the newest Real4Prep RAC-US PDF dumps from Cloud Storage for free: https://drive.google.com/open?id=11eMRHswCyr1ICmpjbIraFrpXM4GYgbjH