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最高のRAC-GSテスト連続を提供することにおける世界的なリーダーとして、我々は大多数の消費者に包括的なサービスを提供することに専念して、そして統合されたサービスを構築するよう努めます。 さらに、RAC-GS認定トレーニングアプリケーション、インタラクティブ共有、アフターサービスでも画期的な成果を上げました。 実際のところ、私たちの会社はすべてのクライアントのフィッティングソリューションに対する困難を考慮に入れています。 あなたが助けを必要とする限り、Regulatory Affairs Certification (RAC) Global Scopeガイドの連続に関する問題のいずれかに対処するための即時サポートを提供します。 いつでも利用可能です。 私たちの責任あるスタッフが質問に答えてくれます。

ハイパスレート

近年、RAC-GSテスト連続は好評を博しており、すべての献身的な努力で99％の合格率に達しています。 より多くの労働者がより高い自己啓発を進めるための強力なツールとして、RAC-GS認定トレーニングは高度なパフォーマンスと人間中心の技術への情熱を追求し続けています。 さまざまな種類の受験者がRegulatory Affairs Certification (RAC) Global Scope認定を受けるのをどのように手助けするかを理解するために多くの研究が行われてきました。 シラバスの変更および理論と実践における最新の動向に従って、Regulatory Affairs Certification (RAC) Global Scopeガイドの連続を修正して更新します。 私たちは、厳密な分析を通じて、近年のテストと業界の動向に基づいてRAC-GS認定トレーニングを行います。

RAPS Regulatory Affairs Certification (RAC) Global Scope 認定 RAC-GS 試験問題:

1. What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A) Quality and effectiveness
B) Safety and effectiveness
C) Safety and failure risk
D) Quality and failure risk

2. 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?

A) Complete a gap analysis to identify options.
B) Qualify another supplier and execute a supplier agreement.
C) Reformulate the products with a replacement material.
D) Review the company's existing Quality ManagementSystem

3. 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) Safety-related reporting
C) Regulatory application summary
D) Risk management process

4. A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X.
where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

A) Submit the product for review as a pharmaceutical product in Country Y.
B) Apply for review of the additional part of the product as a pharmaceutical product in Country
C) E. Examine decisions made about similar products in Country Y to propose the classification ofthe product.
D) Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

5. A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

A) Review the content of change and supporting data for the equivalency with the current material.
B) No action is needed in this situation.
C) Write a memo to file since the change does not impact product safety and effectiveness.
D) Prepare regulatory submissions that detail the medical device's change in materials.

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