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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.
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| Section | Objectives |
|---|---|
| Post-Market Surveillance | - Lifecycle management and variations - Pharmacovigilance and safety reporting |
| Drug Development Lifecycle | - Clinical trial design and regulatory requirements - Preclinical and clinical development stages |
| Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
| Regulatory Foundations | - Regulatory ethics and compliance principles - Global regulatory systems and authorities |
| Regulatory Submissions | - Global marketing authorization applications - Dossier preparation (eCTD and regional formats) |
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