Module 12 2019

Learning Outcomes

❑ Explain the importance of data, document and information management ❑ Demonstrate a critical understanding of the processes and requirements necessary for completing an eCTD

❑ Critically evaluate the IDMP requirements

❑ Identify issues with electronic compliance

❑ Make recommendations about regulatory information management and IDMP strategies ❑ Critically analyse data and documentation strategies and processes

❑ Critically appraise regulatory processes and documentation

The Organisation for Professionals in Regulatory Affairs