Learning objectives

• Knowledge of applicable content and format for different regulatory applications, submissions and approvals
• Skills to plan, project manage and how to compile applications for various submissions
• Competence to support in planning and execution of different regulatory submissions during
the product’s life cycle and provide regulatory guidance on documentation
requirements and format


Course outline

• Regulatory compliance – why? (Documentation requirements then and now, archiving
requirements, traceability, Good Documentation Practice systems)
• Documentation structure – to authority (eCTD, Publishing in electronic submission platforms,
communication with regulatory authorities)
• Documentation structure – internally (Document management – manual vs electronic systems,
version control, product and submission overviews)
• Audit and inspection (Internal and by health authority)
• Regulatory project management (Practical tools and guides to lead the crossfunctional team
and keep the time lines)
• Future documentation requirements – possibilities and potential risk aspects? (eCTD
4.0 and more)