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