Module 1 2021

25/06/2021

Conclusions

• The acceptance of electronic submissions has been increasing rapidly over the past 10 years • The rapidly increasing document and data requirements of regulatory agencies for the content of their dossiers is a significant driver for this change • This is no longer something that only matters in the ICH regions, some of the keenest adopters are in the growing markets who see technology as a way to challenge and keep up with the bigger agencies • Industry needs to accept this change and embrace it • The key is making the management of electronic documents and submissions a key part of our internal information management strategy (eSubs are no longer just something we create for regulators)

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Conclusions

• We are still a long way from having a single format that is acceptable across the whole world (if this was ever a real possibility) • However, the willingness of the regulators to accept electronic ways of working allows industry to develop more coherent strategies for electronic submissions • Look to move to the highest specification you can support as this will be most flexible in meeting the needs across all countries, and also sets you up for the future

The Organisation for Professionals in Regulatory Affairs

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