CRED 8 Presentations

01/07/2024

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

The Organisation for Professionals in Regulatory Affairs

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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

The Organisation for Professionals in Regulatory Affairs

42