Module 1 2021

25/06/2021

What’s next? (2)

• We should expect to see the electronic transmission of data increase with more portals and gateways ─ The EU is planning to move from CESP and the EMA Gateway to CESSP • The content of the dossier will become more structured with standards introduced for the data ─ Electronic Application Forms to improve the uploading and processing of submissions ─ Structured content to drive compliance for documents like labelling (e.g. SPL in the US) • Eventually, we may see two way communication between applicant and regulator, with the flow in both directions fitting together to show relationships and approval status

The Organisation for Professionals in Regulatory Affairs

53

Conclusions

The Organisation for Professionals in Regulatory Affairs

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