RAC-GS Exam Questions & Answers

Exam Code: RAC-GS

Exam Name: Regulatory Affairs Certification (RAC) Global Scope

Updated: Nov 13, 2024

Q&As: 100

At Passcerty.com, we pride ourselves on the comprehensive nature of our RAC-GS exam dumps, designed meticulously to encompass all key topics and nuances you might encounter during the real examination. Regular updates are a cornerstone of our service, ensuring that our dedicated users always have their hands on the most recent and relevant Q&A dumps. Behind every meticulously curated question and answer lies the hard work of our seasoned team of experts, who bring years of experience and knowledge into crafting these premium materials. And while we are invested in offering top-notch content, we also believe in empowering our community. As a token of our commitment to your success, we're delighted to offer a substantial portion of our resources for free practice. We invite you to make the most of the following content, and wish you every success in your endeavors.


Download Free RAPS RAC-GS Demo

Experience Passcerty.com exam material in PDF version.
Simply submit your e-mail address below to get started with our PDF real exam demo of your RAPS RAC-GS exam.

Instant download
Latest update demo according to real exam

*Email Address

* Our demo shows only a few questions from your selected exam for evaluating purposes

Free RAPS RAC-GS Dumps

Practice These Free Questions and Answers to Pass the RAC Regulatory Affairs Certification Exam

Questions 1

Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.

Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.

D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

Show Answer
Questions 2

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

A. Systematic procedure to review published scientific journals

B. Systematic procedure to review experiences with the products in use

C. Vigilance procedure to ensure the full traceability of the products

D. Vigilance procedure to notify the regulatory authorities about serious incidents

Show Answer
Questions 3

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?

A. Specification

B. Formulation

C. Property

D. Justification

Show Answer
Questions 4

Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

A. Document any failure to follow regulatory compliance processes in employee performancereviews.

B. Develop documented procedures for regulatory compliance processes and train personnel.

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

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

Show Answer
Questions 5

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A. Site license

B. Product license

C. Import license

D. Export license

Show Answer

Viewing Page 1 of 3 pages. Download PDF or Software version with 100 questions