Q17. Which of the following BEST describes the content of the “Physical, Chemical, and
Pharmaceutical Properties and Formulation” section of an IB?

Q18. Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y’s products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

Q19. Why is it necessary to run supplemental safety pharmacology studies?

Q20. A process is ultimately validated to ensure which of the following?

Q21. Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

Q22. 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?

Q23. As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

Q24. Following the introduction of a new regulation, an evaluation of the company’s products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

Q25. Who has the PRIMARY responsibility for recall of products with quality defects?

Q26. An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

Q27. Which term does NOT describe the same concept as the others?

Q28. 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?

Q29. 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?

Q30. A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?

Q31. 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?

Q32. During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

Q33. Which of the following situations does NOT require rapid communication to regulatory authorities?

Q34. A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

Q35. During routine surveillance, a regulatory authority sent a company the following communication: “Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company’s product. The regulatory authority is evaluating these issues to determine the need for any regulatory action.” Which action would be the most appropriate
FIRST step for the company to take?

Q36. During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

Q37. A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

Q38. According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

Q39. 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?

Q40. 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?