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
Made with FlippingBook - Online catalogs