Module 12 2019

Submission Units Introduced to have a better way to manage regulatory activities • Submission Unit - will describe actions within that regulatory activity ₋ initial ₋ validation-response ₋ response ₋ additional-info ₋ closing ₋ consolidation ₋ corrigendum ₋ reformat Example: • var-type2 • initial • validation-response • response • closing • extension • initial • response • closing

The Organisation for Professionals in Regulatory Affairs