IT Certification Exam Questions & Answers

NO.38 According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?

NO.39 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?

NO.40 Company X is planning to acquire the rights for a product marketed by Company Y. As part of due
diligence, what is the MOST important information the Company X regulatory affairs professional should
ask senior management to request from Company Y?

NO.41 A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for
review and approval. The regulatory authority issues the company a written commitment that if the studies
are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and
safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified
criteria, the company receives a letter from the regulatory authority stating that it no longer believes that
the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

NO.42 In addition to protection, what parameters MUST be considered when selecting the primary package (or a
product?

NO.43 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?

NO.44 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?

NO.45 As a member of the product launch review committee, a regulatory affairs professional discovers a major
issue with the labeling of a product prior to production. In addition to informing the committee, which is the
BEST approach to address the issue?

NO.46 Which of the following is MOST appropriate for the purpose of lot release of biologics?

NO.47 A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?

NO.48 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.49 Which of the following is NOT required to be included in a marketing application?

NO.50 Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?

NO.51 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?

NO.52 Which of the following statements regarding export regulations for an approved product is CORRECT?

NO.53 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?