Regulatory Affairs Certification (RAC) Global Scope
Last Update 4 days ago
Total Questions : 100
RAC-GS is stable now with all latest exam questions are added 4 days ago. Just download our Full package and start your journey with RAPS Regulatory Affairs Certification (RAC) Global Scope certification. All these RAPS RAC-GS practice exam questions are real and verified by our Experts in the related industry fields.
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
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?
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
In which section of the ICH Common Technical Document will the overview of clinical data appear?
Which of the following statements regarding export regulations for an approved product is CORRECT?
A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability study?
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?
TESTED 27 Apr 2024
Hi this is Romona Kearns from Holland and I would like to tell you that I passed my exam with the use of exams4sure dumps. I got same questions in my exam that I prepared from your test engine software. I will recommend your site to all my friends for sure.
Our all material is important and it will be handy for you. If you have short time for exam so, we are sure with the use of it you will pass it easily with good marks. If you will not pass so, you could feel free to claim your refund. We will give 100% money back guarantee if our customers will not satisfy with our products.
