Regulatory Affairs Certification Exam Preparation

1

• RAC
• Regulatory Affairs Certification

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What is Regulatory Affairs (RAC)?
Regulatory affairs is a comparatively new
profession which developed from the desire of
governments to protect public health by
controlling the safety and efficacy of products
in areas including pharmaceuticals, veterinary
medicines, medical devices, pesticides,
agrochemicals, cosmetics and complementary
medicines.
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Regulatory Affairs Procedure
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During a routine review of promotional materials
for a product, a regulatory affairs professional
discovers an off-label indication. Which of the
following would be the FIRST follow-up action for
the regulatory affairs professional to take?
A. Allow doctors to use the product for the
off-label indication. B. Communicate with the
sales department to stop using the promotional
materials. C. Contact the marketing department to
recall the product. D. Request that doctors stop
using the product for the off-label
indication. Answer B
10
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?
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. Answer C
11
Which of the following is an example of an
acceptable statement for an advertisement of
an approved arthritis medication?
A. "Product X is a guaranteed cure for
arthritis." B. "Product X is effective for the
treatment of arthritis." C. "Product X is safe
for arthritis and without side effects." D.
"Product X is effective in all patients with
arthritis." Answer B
12
Which of the following statements regarding the
off-label use of drugs is CORRECT?
A. Although the regulatory authority reviews and
approves drugs for specific indications, theapprov
al does not limit the use of those drugs in
clinical practice. B. The regulatory authority
does not restrict physician prescribing for
off-label indications orregulate the
manufacturer's promotion for such use. C.
Sponsors are allowed to distribute publications
about unapproved uses of approved drugs and
devices as long as the marketing application is
under review by the regulatory authority. D. The
peer-reviewed literature can ensure high-quality
off-label promotion of medications, thereby
increasing accessto much needed drugs and
devices. Answer A
13
According to the GHTF, which of the following is
NOT an exemption rule when evaluating the
decision to report an adverse event?
A. Deficiency of a device found by the user prior
to patient use B. Adverse event caused by patient
conditions C. Malfunction occurring before the
end of service life of the medical device D.
Malfunction protection operated
correctly Answer B,C
14
GHTF recommends that the medical device
manufacturer define the scope of the
clinical evaluation based on which of the
following?
A. Instructions for use B. Risk analysis C.
Product literature D. Essential
principles Answer B,D
15
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?
A. Labeling B. Regulatory application summary C.
Risk management process D. Safety-related
reporting Answer A
16
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?
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 Answer B
17
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• RAC
• Regulatory Affairs Certification

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