Module 12 2019

ROG: Regulatory Optimisation Group • The Regulatory Optimisation Group (ROG) is a an HMA subgroup focused on regulatory/business optimization under HMA Multi Annual Working Plan priority Optimization of the regulatory operations, objective 2, Strive for operational excellence. http://www.hma.eu/512.html • 6 Industry (H/V) and 10 Agency representatives + EMA CMDh and CMDv involved • Role: Preparing business cases that are approved by HMA/EMA o First business case to reduce effort for type IA variations => report variations directly as structured SPOR data in SPOR database

The Organisation for Professionals in Regulatory Affairs