QUESTION 28
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

QUESTION 29
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?

QUESTION 30
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

QUESTION 31
A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?

QUESTION 32
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

QUESTION 33
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?

QUESTION 34
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?

QUESTION 35
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?

QUESTION 36
Who has the PRIMARY responsibility for recall of products with quality defects?

QUESTION 37
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

QUESTION 38
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?

QUESTION 39
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

QUESTION 40
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

QUESTION 41
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

QUESTION 42
Which of the following BEST describes the purpose of the ICH?

QUESTION 43
A process is ultimately validated to ensure which of the following?

QUESTION 44
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?

QUESTION 45
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?

QUESTION 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?

QUESTION 47
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

QUESTION 48
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?