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What is Regulatory Affairs (RAC)?

Regulatory affairs is a comparatively new profession which developed fromthe desire of governments to protect public health by controlling the safetyand efficacy of products in areas including pharmaceuticals, veterinarymedicines, medical devices, pesticides, agrochemicals, cosmetics andcomplementary medicines.




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RAC Exam Test

RAC exam is not easy to pass. Beforeattempting to take the exam, you must havea complete knowledge of this. If you want tobecome certified RAC then you can get helpfrom Exams4sure real exam material for RACexam. Here we present the latest questionsand answers for the RAC certification exam




Question No 1

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

Question No 2

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 developmentphase.D. Plan regulatory approval update meetings with senior management and stakeholders.

Answer: C

Question No 3

Which of the following is an example of an acceptable statement for an advertisement of anapproved 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

Question No 4

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,theapproval does not limit the use of those drugs in clinical practice.B. The regulatory authority does not restrict physician prescribing for off-label indicationsorregulate the manufacturer's promotion for such use.C. Sponsors are allowed to distribute publications about unapproved uses of approveddrugs and devices as long as the marketing application is under review by the regulatoryauthority.D. The peer-reviewed literature can ensure high-quality off-label promotion of medications,thereby increasing accessto much needed drugs and devices.

Answer: A

Question No 5

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 useB. Adverse event caused by patient conditionsC. Malfunction occurring before the end of service life of the medical deviceD. Malfunction protection operated correctly

Answer: B,C

Question No 6

GHTF recommends that the medical device manufacturer define the scope of the clinicalevaluation based on which of the following?

A. Instructions for useB. Risk analysisC. Product literatureD. Essential principles

Answer: B,D

Question No 7

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. LabelingB. Regulatory application summaryC. Risk management processD. Safety-related reporting

Answer: A

Question No 8

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 AgreementB. The stability of the drug in all zone conditionsC. The time frame in which the patent will expireD. International import and export regulations

Answer: B

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