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 Madrid system.
B. Use the community patent system.
C. File patents of interest in target countries.
D. File design patents in target countries.
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
A. Ask the vendor to take responsibility.
B. Document and perform audits.
C. Request an inspection from a regulatory authority.
D. Request documentation from the sub-contractor.
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?
A. Documented agreement
B. Frequent communication
C. Early collaboration
D. Follow-up meeting after submission
Which of the following claims would classify an apple as a drug?
A. "It will make you look younger."
B. "It will satisfy hunger."
C. "It will whiten teeth."
D. "It will prevent colds."
At a recent scientific meeting,Company Y had two booths:
At one booth,Company Y provided brochures on a completed Phase II study.
In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
A. Acknowledge receipt of the letter in a written response but do nothing further.
B. Inform the legal department of the letter and discuss how to respond.
C. Inform Company X that it has no right to send such a letter and do nothing further.
D. Inform the local regulatory authority of the letter and discuss how to respond.
Which of the following situations does NOT require rapid communication to regulatory authorities?
A. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
C. A major safety finding from a newly completed animal carcinogenicity study
D. A statistically significant increase in the number of deaths in an animal dose finding study
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 GMP
B. Certificate of Free Sale
C. Certificate of Pharmaceutical Product
D. Certificate of Analysis for the finished product
A company is developing a new line of products in an area that is new to the company. What is the BEST approach?
A. Ask the trade association representative to provide an overview of the new product area to the marketing team.
B. Obtain competitor research and provide the information to the management team.
C. Obtain regulatory documents and history and provide the information to RandD.
D. Summarize regulatory documents and history and provide the information to the management team.
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?
A. Allow the auditor access to the room and records due to the current audit.
B. Allow the auditor accompanied access to the room to retrieve the records.
C. Deny the auditor access to the room and retrieve only the requested records.
D. Deny the auditor access to the room and records due to confidentiality concerns.
During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?
A. Allow doctors to use the product for the off-label indication.
B. Communicate with the sales department to stop using the promotional materials.
C. Contact the marketing department to recall the product.
D. Request that doctors stop using the product for the off-label indication.
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