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RAC-GS exam dumps elaborated the detailed info about the exam. The overview of the info about Passing Score, Duration & Question for the RAPS RAC-GS Certification is given below:
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The candidates are required to have at least a bachelor's degree or equivalent and two years of relevant experience in the healthcare product sector. They are also needed to have at least one year of professional experience in Regulatory Affairs. Premarket approval required by the regulatory agency is also needed for those candidates who wish to take the RAC-GS Certification Exam.
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Regulatory Submissions & Approval | 20% | - Global Dossiers & Submission Formats
|
| Topic 2: Global Regulatory Environment & Strategy | 35% | - International Regulatory Frameworks
|
| Topic 3: Post-Market Compliance & Surveillance | 20% | - Labeling, Advertising & Changes
|
| Topic 4: Product Development & Lifecycle Management | 25% | - Chemistry, Manufacturing & Controls
|
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