The future of regulatory affairs​

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.

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