Online Access Free RAC-GS Practice Test

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?

• A.The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
• B.The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
• C.The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
• D.The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

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?

• A.Prepare the international monograph change submission first and then prepare the local change when required.
• B.Transfer the notice of the upcoming international monograph change to QA for further processing.
• C.Confirm that the international monograph change is not related to local pharmacopeia.
• D.Analyze the impact of the international monograph change on the local pharmacopeia.

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

• A.Product requirements
• B.Product registration
• C.Product formulation
• D.Product stability

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?

• A.Compare the approved text with the product label
• B.Notify the regulatory authority.
• C.Inform the production team.
• D.Recommend an immediate product recall.

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?

• A.Stop product manufacturing.
• B.Review the stability data for the changes.
• C.Establish validation procedures.
• D.Assess the impact of the changes.