Free PDF 2025 RAPS RAC-GS: Regulatory Affairs Certification (RAC) Global Scope Fantastic Reliable Learning Materials

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Obtaining the RAPS RAC-GS Certification is a significant achievement for regulatory professionals as it demonstrates their commitment to their profession and their dedication to staying up-to-date with the latest regulatory developments. It also highlights their expertise in navigating the complex and ever-changing regulatory landscape. Regulatory Affairs Certification (RAC) Global Scope certification is recognized globally and is highly respected among regulatory professionals, providing a significant advantage for those who hold it when it comes to career advancement and job opportunities.

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RAPS RAC-GS Certification Exam is a rigorous and comprehensive exam that covers various regulatory aspects such as the regulatory environment, product development, submission and approval processes, post-approval requirements, and international regulations. It is designed to assess the proficiency of professionals in regulatory affairs and their ability to apply their knowledge in practical settings.

RAPS Regulatory Affairs Certification (RAC) Global Scope Sample Questions (Q79-Q84):

NEW QUESTION # 79
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?

A. Document and perform audits.
B. Request an inspection from a regulatory authority.
C. Request documentation from the sub-contractor.
D. Ask the vendor to take responsibility.

Answer: A

NEW QUESTION # 80
Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical
Properties and Formulation" section of an IB?

A. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation
method of the finished product
B. A review of available data to support the determination of the chemical structure and physical attributes
of the drug substance plus batch analysis and stability data for the finished formulation
C. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage
and handling of the dosage form: and a description of the formulation
D. A detailed summary of the physical and chemical properties of the drug product with a signed expert
statement addressing the suitability and stability of the formulation for its intended use

Answer: C

NEW QUESTION # 81
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?

A. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application.
B. Request a meeting with the regulatory authority to discuss the application.
C. Consult with the legal department to discuss the best course of action.
D. Review the regulatory guidelines to determine how to proceed.

Answer: B

NEW QUESTION # 82
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?

A. Written procedure for product traceability
B. Local reimbursement requirements
C. Service operation procedures .
D. Training program for sales people

Answer: D

NEW QUESTION # 83
The intermediate manufacturing process was changed during development of a pharmaceutical. The
change may impact the API specification. Which functional area is responsible for the final approval of the
change?

A. Production
B. Analytical
C. Quality
D. Regulatory

Answer: C

NEW QUESTION # 84
......

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