Regulatory Certification Exam (RAC) - Global Scope

#1
Hi everyone

For those who have taken the Global Scope exam, what study tips can you offer? Is it sufficient to read the Fundamentals textbook? Or should we also go over the ICH guidelines?

Thank you.
 
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#2
You can read the GHTF documents (they are archived at the IMDRF website). When I took the exam, it was heavy based on risk management, including a lot of device questions, so you should probably look at ISO 14971 also if possible.
 
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