Pass RAPS RAC-US Exam Quickly With ExamsLabs [Q46-Q60] : Exams Labs Braindumps : http://blog.examslabs.com

Q46. 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.

Q47. 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

Q48. 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?

Specification

Formulation

Property

Justification

Q49. Which of the following BEST describes the purpose of the ICH?

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

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

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

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

Q50. A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company’s products. What action should the company take FIRST?

Review the company’s existing Quality Management System

Reformulate the products with a replacement material.

Qualify another supplier and execute a supplier agreement.

Complete a gap analysis to identify options.

Q51. 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?

Utilize the STED template to complete global requirements.

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

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

Plan regulatory approval update meetings with senior management and stakeholders.

Q52. A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

Expiration date

Relevance to regulations

Revision history

Scope and level of detail

Q53. An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

Stop product manufacturing.

Establish validation procedures.

Assess the impact of the changes.

Review the stability data for the changes.

Q54. 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

Q55. In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

Potential clinical sites for the Phase III clinical trial

Regulatory requirements for labeling and packaging

Capacity of the manufacturing facilities to fully produce the new product

Previous actions taken by regulatory authorities on similar products

Q56. A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

Labeling

Regulatory application summary

Risk management process

Safety-related reporting

Q57. 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.

Q58. A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.

Consult with the legal department to discuss the best course of action.

Review the regulatory guidelines to determine how to proceed.

Request a meeting with the regulatory authority to discuss the application.

Q59. During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

Withdraw the affected product from the markets.

Send a “Dear Dr.” letter to customers.

Notify the global regulatory authorities.

Assess the potential safety risk.

Q60. A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

Adverse event reports

Clinical experience

Clinical investigations

Literature search