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What is the Prerequisite for taking the RAPS RAC-GS Certification Exam?
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.
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- In the United States: 80,000 USD
- In Canada: 80,000 CDN
- In India: 65,000 INR
- In Australia: 70,000 AUD
- In the UK: 65,000 GBP
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RAPS RAC-GS Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Regulatory Submissions | - Global marketing authorization applications - Dossier preparation (eCTD and regional formats) |
| Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
| Drug Development Lifecycle | - Clinical trial design and regulatory requirements - Preclinical and clinical development stages |
| Post-Market Surveillance | - Pharmacovigilance and safety reporting - Lifecycle management and variations |
| Regulatory Strategy and Compliance | - Regulatory strategy development - Quality systems and inspections |
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