Free RAPS RAC-US Exam Dumps Questions & Answers

A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

• A.  The stability of the drug in all zone conditions
• B.  Doha Declaration in the TRIPS Agreement
• C.  The time frame in which the patent will expire
• D.  International import and export regulations

During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

• A.  Terminate the PI and inform the regulatory authorities.
• B.  Increase the frequency of monitoring visits.
• C.  Send a letter of complaint to the Ethics Committee that approved the site.
• D.  Inform the institution that granted a medical license to the Pi.

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?

• A.  Explore litigation strategy for patent infringements on the drug.
• B.  Develop a generic version of the drug.
• C.  Develop a better brand-name drug in the same class.
• D.  Conduct a Phase III study for a new unrelated indication of the drug.

A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?

• A.  Use the community patent system.
• B.  File patents of interest in target countries.
• C.  File design patents in target countries.
• D.  Use the Madrid system.

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

• A.  Written procedure for product traceability
• B.  Service operation procedures
• C.  Local reimbursement requirements
• D.  Training program for sales people