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Free RAC-GS Exam Braindumps (page: 11)

Page 11 of 26
PDF with 100 Questions

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

  1. "Is the product profitable for the manufacturer?"
  2. "Is the product better than currently available alternatives?"
  3. "Has the product been approved for mor&4nan 10 years?"
  4. "Is the product an established gold standard?"

Answer(s): B



Which of the following situations does NOT require rapid communication to regulatory authorities?

  1. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
  2. A lack of efficacy with a medicinal product used in treating a life-threatening disease
  3. A major safety finding from a newly completed animal carcinogenicity study
  4. A statistically significant increase in the number of deaths in an animal dose finding study

Answer(s): A,D



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?

  1. Certificate of GMP
  2. Certificate of Free Sale
  3. Certificate of Pharmaceutical Product
  4. Certificate of Analysis for the finished product

Answer(s): C



A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

  1. Ask the trade association representative to provide an overview of the new product area to the marketing team.
  2. Obtain competitor research and provide the information to the management team.
  3. Obtain regulatory documents and history and provide the information to R&D.
  4. Summarize regulatory documents and history and provide the information to the management team.

Answer(s): D



Page 11 of 26



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Raymond commented on May 02, 2022
Best way to cheat your exam. hahaha... all questions are in this dexam dump.
UNITED STATES
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