Duration: 2 Days
Delivery Format: Online
Enhance your expertise in pharmaceutical regulatory affairs with our Common Technical Document (CTD) for Human Drug Registration online training course. This practical program provides a comprehensive overview of CTD and eCTD requirements, SFDA guidelines, and the key elements involved in preparing successful regulatory submissions.
Participants will gain a comprehensive overview of CTD Modules 1–5 and the quality, non-clinical, and clinical documentation requirements for human drug registration in accordance with SFDA guidelines. The course also addresses common deficiencies in drug substance and drug product documentation and introduces eCTD concepts through practical examples and discussions.
Designed for regulatory affairs professionals, pharmacists, quality assurance personnel, and individuals involved in pharmaceutical development and drug registration, this course will help strengthen your understanding of international regulatory requirements and best practices.
