Regulatory documentation, content and format guide

About the course

Ever longed for support on how to ensure regulatory documentation compliance internally and towards authority? Or on how to effectively project lead cross functional teams to meet the required timelines? This course gives you the insight of the do’s and don’ts and is a practical guide to current requirements and tools as well as a sneak-peak into the near future solutions, such as eCTD 4.0. The course is given in English.

Who should attend?

This course is recommended for Regulatory Affairs Managers or Regulatory Affairs Managers to be, who seek practical documentation guidance. We recommend having knowledge or experience equivalent to Läkemedelsakademin’s Basics of Regulatory Affairs at the least, to fully understand and benefit from the course.

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)