NO.46 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?

NO.47 One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority’s request?

NO.48 What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

NO.49 During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

NO.50 According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

NO.51 A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

NO.52 A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

NO.53 Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

NO.54 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?

NO.55 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?

NO.56 When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

NO.57 Which of the following BEST describes the purpose of the ICH?

NO.58 Which of the following BEST describes the content of the “Physical, Chemical, and
Pharmaceutical Properties and Formulation” section of an IB?

NO.59 Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

NO.60 The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?

NO.61 GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

NO.62 The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

NO.63 Which term does NOT describe the same concept as the others?

NO.64 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?

NO.65 Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

NO.66 A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

NO.67 A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

NO.68 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?