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NEW QUESTION 48
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
Answer: C
NEW QUESTION 49
Which of the following BEST describes the purpose of the ICH?
Answer: A
NEW QUESTION 50
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?
Answer: A
NEW QUESTION 51
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?
Answer: A
NEW QUESTION 52
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?
Answer: C
NEW QUESTION 53
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