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To be eligible for the RAC-US exam, candidates must possess a minimum of three years of regulatory experience and a bachelor’s degree in a related field. Alternatively, candidates with a master’s degree in a related field can be eligible with only two years of regulatory experience. The RAC-US exam is a computer-based test consisting of 150 multiple-choice questions that must be completed within four hours. Candidates who successfully pass the exam are awarded the RAC-US certification, which is valid for three years.

NO.34 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?

Use the Madrid system.

Use the community patent system.

File patents of interest in target countries.

File design patents in target countries.

NO.35 What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

Ask the vendor to take responsibility.

Document and perform audits.

Request an inspection from a regulatory authority.

Request documentation from the sub-contractor.

NO.36 The requirements for document control are located in which of the following documents?

ICH guidelines

IEC 60601

ISO 13485

WHO guidelines

NO.37 The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

100 patients for 12 months

200 patients for nine months

500 patients for three months

3.000 total patient exposures

NO.38 A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

Submit the product for review as a pharmaceutical product in Country Y.

Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

Apply for review of the additional part of the product as a pharmaceutical product in Country

Examine decisions made about similar products in Country Y to propose the classification of the product.

NO.39 A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

No action is needed in this situation.

Prepare regulatory submissions that detail the medical device’s change in materials.

Review the content of change and supporting data for the equivalency with the current material.

Write a memo to file since the change does not impact product safety and effectiveness.

NO.40 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?

Allow the auditor access to the room and records due to the current audit.

Allow the auditor accompanied access to the room to retrieve the records.

Deny the auditor access to the room and retrieve only the requested records.

Deny the auditor access to the room and records due to confidentiality concerns.

NO.41 According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

Class A

Class B

Class C

Class D

NO.42 Which of the following is MOST appropriate for the purpose of lot release of biologics?

Inventory control

Safety assurance

Efficacy confirmation

Quality verification

NO.43 In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

Discuss with the regulatory apriority and attempt to reach an acceptable solution.

Inform the internal departments to redesign the product to comply with this requirement.

Inform the regulatory authority that such a requirement is not applicable to the product.

Notify senior management that the product cannot be registered.

NO.44 A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

Ask the trade association representative to provide an overview of the new product area to the marketing team.

Obtain competitor research and provide the information to the management team.

Obtain regulatory documents and history and provide the information to R&D.

Summarize regulatory documents and history and provide the information to the management team.

NO.45 During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

Perform either an identification study or a non-clinical qualification study.

Perform both identification and non-clinical qualification studies concurrently.

Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

NO.46 In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

Volume and material

Compatibility and safety

Safety and efficacy

Efficacy and material

NO.47 According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

Deficiency of a device found by the user prior to patient use

Adverse event caused by patient conditions

Malfunction occurring before the end of service life of the medical device

Malfunction protection operated correctly

NO.48 A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

For at least two years after the last approval of an application in an ICH region

For a minimum of 10 years after completion of the clinical study

Three years after the last clinical study site was supplied with investigational drugs

Until the product has been discontinued from marketing in all ICH regions

NO.49 Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

Document any failure to follow regulatory compliance processes in employee performance reviews.

Develop documented procedures for regulatory compliance processes and train personnel.

Train all new employees on regulatory compliance processes and assign a mentor to them.

Train employees on all regulatory compliance processes using state-of-the-art systems.

NO.50 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?

The ISO national member body

The ISO technical committee in charge of the area

The ISO Secretariat

The country’s regulatory authority

NO.51 According to ICH, which of the following components of study information is NOT required in a clinical study report?

Randomization scheme and codes

Protocol and protocol amendments

List of lECs or lRBs

Detailed CV of all investigators

NO.52 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?

Doha Declaration in the TRIPS Agreement

The stability of the drug in all zone conditions

The time frame in which the patent will expire

International import and export regulations

NO.53 What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

Safety and failure risk

Safety and effectiveness

Quality and failure risk

Quality and effectiveness

NO.54 GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

Instructions for use

Risk analysis

Product literature

Essential principles

NO.55 Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

Intellectual properly

Clinical trial data

Safety issues

Marketing materials

NO.56 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?

Acknowledge receipt of the letter in a written response but do nothing further.

Inform the legal department of the letter and discuss how to respond.

Inform Company X that it has no right to send such a letter and do nothing further.

Inform the local regulatory authority of the letter and discuss how to respond.

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