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Syllabus |
Regulatory affairs in European Union (EU) and European regulatory system for human medicines. National and EU legislation and guidelines (Eudralex). The role of the regulatory affairs professional. Drug development under regulatory compliance: current Good X Practices (cGxP – GMP, GLP, GCP). Nonclinical development, pharmaceutical development and quality, clinical development, and pharmacovigilance and risk management. Marketing authorization application dossier: content and format. Common Technical Document (CTD) and eCTD. Centralized, mutual recognition, decentralized and national procedures. Types of applications: complete, generic, hybrid, well-established use, fixed combination, and informed consent applications, and traditional use registration for herbal medicinal products. Lifecycle management: key elements for the maintenance of a marketing authorization. Line extension and variation applications. Legal status, renewal and periodic safety reports.
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