Module 12 2019

Impact on Regulatory Affairs • Data sharing throughout life cycle of the product From early development, throughout registration, until marketing and pharmacovigilance • Data governance o When is data generated, o Used and re-used, o By who,

o For which purpose, o By which system, etc

• Linking data between systems • Reduction of duplication of data • Use of Master Data throughout the organisation

The Organisation for Professionals in Regulatory Affairs