Module 12 Presentations

Regulatory Intelligence impact assessment

• Incoming Regulatory Intelligence requires an effective organizational impact assessment :

• By a dedicated Team or department (usually larger Companies)

• Incorporated in an existing role (usually small/medium companies)

• By use of dedicated technology for Reg. Intel monitoring

• Provided by a dedicated outsourcing partner

• Key to bring in the right experts that understand Global and Local implications, classify the relevance and ensure that the right people are informed and involved • All aspects need to be considered for Regulatory impact assessments: Process, Organization, Information and Technology

The Organisation for Professionals in Regulatory Affairs