Free RAPS RAC-US Exam Dumps Questions & Answers

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

• A.Adverse environmental impacts
• B.Causes of non-conformities
• C.Inadequate training
• D.Late and/or incorrect deliverables

During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

• A.As many as required by international standards
• B.As many as government attendees
• C.All senior management from the main office
• D.The minimum number of attendees necessary to address the issues

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

Which of the following situations does NOT require rapid communication to regulatory authorities?

• A.A statistically significant increase in the number of deaths in an animal dose finding study
• B.A clinically important increase in the rate of occurrence of an "expected." but serious
  ADR
• C.A lack of efficacy with a medicinal product used in treating a life-threatening disease
• D.A major safety finding from a newly completed animal carcinogenicity study

A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

• A.Relevance to regulations
• B.Revision history
• C.Scope and level of detail
• D.Expiration date