CRED ERP 25

01/07/2025

Choice of procedure

• No single “golden rule” for strategic considerations

• Assess the appropriateness of your strategy on a case-by-case basis

• Centralised Procedure vs. DCP / MRP / National • Accessibility vs. flexibility • Evaluate the pros and cons

• Ensure alignment of the filing plans with the commercial strategy

• Understand and accommodate internal decision-making processes into plans

• Review against emerging internal/external factors until the filing

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Project planning is critical

• EU strategy is a key component of the global strategy

• Drive process and set optimal filing dates

• Build time for pre-submission meetings into overall timelines

• Ensure rapid response team coverage from pre-submission through to approval

• Communication with external and internal stakeholders is key

• Integrate potential conditional approval/ exceptional circumstances into strategy and address them as part of scientific advice discussions

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