Q24. 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?

Q25. A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?

Q26. What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

Q27. According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

Q28. A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

Q29. What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

Q30. According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

Q31. The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

Q32. Which term does NOT describe the same concept as the others?

Q33. A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

Q34. Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

Q35. 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?

Q36. In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

Q37. The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product’s manufacturer FIRST do in
Country Y?

Q38. Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

Q39. A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

Q40. At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?