Module 12 2019

AGENDA

1. Introductions – who are we? Who are you? 2. Genesis of the course 3. What we intend to cover and what is out of scope 4. How the days will run • Day 1 – Basics of DataM/DG/DocM • Day 2 – Deeper Dives on eCTD, US Reg Requirements, EU Telematics, Technical Specs, RIM1 and RIM2 • Day 3 – Implications and Influencing

Emphasis on content delivery and active learning

The Organisation for Professionals in Regulatory Affairs