F. Regulatory and Clinical Development
CTD Dossier Preparation
Provides a structured approach to compiling a Common Technical Document dossier.
Duration8 hours
Best ForRegulatory, R&D, QA, QC and product-development personnel
FormatLive workshop or customized regulatory program
Provides a structured approach to compiling a Common Technical Document dossier. Participants review the purpose and content of each module, document planning, quality summaries, pharmaceutical-development evidence, specifications, validation, stability and submission readiness.