Regulatory Affairs organisations interface with many internal and external stakeholders and will need to continue to respond to a dynamic and evolving environment. We outline 5 priorities that Regulatory Affairs organisations must explore in order to prepare for the future:
- Enhance the Regulatory Affairs and Pharmacovigilance interface
- Optimise outsourcing
- Prepare for new modalities
- Drive efficiencies and quality through automation
- Explore machine learning and artificial intelligence
This will also require organisations to reassess the roles and profiles of Regulatory Affairs professionals at all levels.