Year End Sale - Special Limited Time 55% Discount Offer - Ends in 0d 00h 00m 00s - Coupon code: 44314956B5

Good News !!! RAC-US Regulatory Affairs Certification (RAC) US is now Stable and Pass

RAC-US Regulatory Affairs Certification (RAC) US Question and Answers

Regulatory Affairs Certification (RAC) US

Last Update 13 hours ago
Total Questions : 100

RAC-US Exam is stable now with all latest questions are added 13 hours ago. Just download our Full package and start your journey with RAPS Regulatory Affairs Certification (RAC) US certification. All these RAPS Exam RAC-US questions are real and verified by our Experts in the related industry fields.

RAC-US PDF

RAC-US PDF (Printable)
$94.05
$209

RAC-US Testing Engine

RAC-US PDF (Printable)
$134.55
$299

RAC-US PDF + Testing Engine

RAC-US PDF (Printable)
$157.05
$349
Question # 1

According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability study?

Options:

A.  

25: C and 60% RH

B.  

30° C and 35% RH

C.  

30c C and 65% RH

D.  

30: C and 75% RH

Discussion 0
Question # 2

Which of the following is the PRIMARY purpose of an audit report?

Options:

A.  

To carry out a complete review of product applications

B.  

To define how to prepare new product submissions

C.  

To document compliance history

D.  

To train sales representatives

Discussion 0
Question # 3

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

Options:

A.  

Utilize the STED template to complete global requirements.

B.  

Initiate a global submission process after all submission data are finalized.

C.  

Identify countries where special requirements exist during the product development phase.

D.  

Plan regulatory approval update meetings with senior management and stakeholders.

Discussion 0
Question # 4

During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate FIRST step for the company to take?

Options:

A.  

Contact the regulatory authority to argue that its conclusions are wrong.

B.  

Contact the regulatory authority to discuss its findings.

C.  

Repeat the Hepatotoxicity tests and send the results to the regulatory authority.

D.  

Wait for the regulatory authority's final publication on its findings.

Discussion 0
Question # 5

A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

Options:

A.  

Specification

B.  

Formulation

C.  

Property

D.  

Justification

Discussion 0
Question # 6

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?

Options:

A.  

Doha Declaration in the TRIPS Agreement

B.  

The stability of the drug in all zone conditions

C.  

The time frame in which the patent will expire

D.  

International import and export regulations

Discussion 0
Question # 7

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?

Options:

A.  

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

B.  

Perform both identification and non-clinical qualification studies concurrently.

C.  

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

D.  

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

Discussion 0
Question # 8

A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

Options:

A.  

Concept development and validation

B.  

Concept development and early technical design

C.  

Early technical design and product release

D.  

Product release and validation

Discussion 0
Question # 9

GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

Options:

A.  

Instructions for use

B.  

Risk analysis

C.  

Product literature

D.  

Essential principles

Discussion 0
Question # 10

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

Options:

A.  

Documented agreement

B.  

Frequent communication

C.  

Early collaboration

D.  

Follow-up meeting after submission

Discussion 0
Question # 11

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?

Options:

A.  

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

B.  

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

C.  

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

D.  

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

Discussion 0
Question # 12

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

Options:

A.  

Inadequate training

B.  

Late and/or incorrect deliverables

C.  

Causes of non-conformities

D.  

Adverse environmental impacts

Discussion 0
Question # 13

According to ICH, which of the following components of study information is NOT required in a clinical study report?

Options:

A.  

Randomization scheme and codes

B.  

Protocol and protocol amendments

C.  

List of lECs or lRBs

D.  

Detailed CV of all investigators

Discussion 0
Question # 14

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?

Options:

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.

Discussion 0
Question # 15

Which of the following BEST describes the purpose of the ICH?

Options:

A.  

To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions

B.  

To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions

C.  

To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions

D.  

To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

Discussion 0