Description

This course includes the following topics:

• Drug development (key documents, guidelines, and regulations)
• A day in the life of a medical writer
• Plain Language Summary
• Clinical summaries and clinical overview
• Project management
• ‘Lean writing (group assignment)
• Hands-on training

Objectives

The main objectives of this course are:

• learn about the importance of a medical writer in drug development
• understand the purpose, importance, and requirements of a Plain Language Summary
• gain insight into advanced regulatory document types, including clinical summaries and the clinical overview
• understand the project management around the writing process towards a finalized document
• understand the principles of lean writing and how to apply them in (clinical) documents including scientific articles and PhD thesis