Module 1 2021

28-6-2021

Aspects of a Regulatory Strategy

• Overview of guidelines and precedents: covered in the lecture on regulatory intelligence • Plan for scientific advice : covered in the lecture on authority consultation • Knowledge on requirements in the regions of interest

The Organisation for Professionals in Regulatory Affairs

11

Aspects of a Regulatory Strategy

• Key product label attributes • External influencing • Global submission strategy: know the requirements in each region • Pharmacoeconomic / Reimbursement aspects • Target submission and approval dates • Options for accelerated approval pathways: covered in the lectures for the various regions • Options for small and medium enterprises

The Organisation for Professionals in Regulatory Affairs

12

6