RAC-GS 試験問題を無料オンラインアクセス

Why is it necessary to run supplemental safety pharmacology studies?

• A.To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
• B.To comply with regulatory authority requirements related to clinical studies
• C.To substitute the utilization of GLP
• D.To provide adverse reaction reports and the results of the statistical data to the regulatory authority

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?

• A.Certificate of Analysis for the finished product
• B.Certificate of Free Sale
• C.Certificate of Pharmaceutical Product
• D.Certificate of GMP

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?

• A.The ISO technical committee in charge of the area
• B.The country's regulatory authority
• C.The ISO national member body
• D.The ISO Secretariat

Which of the following statements regarding export regulations for an approved product is CORRECT?

• A.The product must not be sold or offered for sale in domestic commerce.
• B.The product must not be in conflict with the laws of the country to which it is intended forexport.
• C.The product must not be in accord with the specifications of the foreign purchaser.
• D.The product must not be labeled on the outside of the shipping package that it is intendedfor export.

Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

• A.Systematic procedure to review published scientific journals
• B.Vigilance procedure to notify the regulatory authorities about serious incidents
• C.Vigilance procedure to ensure the full traceability of the products
• D.Systematic procedure to review experiences with the products in use