CRED ERP 25

02/07/2025

Conclusion

Start with the end in mind! • Purely developing a commercially viable label isn’t enough

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• The challenges of developing treatments in increasingly complex, uncertain and ambiguous environments • Requires a fully integrated, intelligent global regulatory strategy

• The pressures of doing more with less! • Smarter resource utilisation by both Sponsors and Regulators

The Organisation for Professionals in Regulatory Affairs

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Thank you!

The Organisation for Professionals in Regulatory Affairs

Prepared by Smarter Biotech Solutions for AstraZeneca & TOPRA

8 Jun 2023

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