CRED 8 Presentations

03/07/2024

Task

• Day 1 (all Case Study groups) 45 mins : • Develop an EU strategy for presentation to company governance board for Case Study 1 • Put yourself in the position of a Regulatory Affairs Director presenting your proposed strategy to the board of directors • Day 2 (all Case Study groups) 1 hour 30 mins : • Describe practical implementation to your regulatory affairs team as part of a company EU Regulatory Affairs department for Case Study 1 • Put yourself in the position of a Regulatory Affairs Director explaining to your departmental team how you want the agreed strategy implemented • Develop an EU strategy for Case Study 2 for presentation to company governance board for and its practical implementation to your regulatory affairs team

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

• Strategy • Focus on developing: Regulatory Strategy • Consider strategic options – advantages/disadvantages • Filing route/Legal Basis • Incentives: Orphan Drug Designation

• Commercial needs • HTA considerations • Data considerations

• Scientific Advice • Justify decisions • Implications of each decision • Presentation to company board (governance)

• Practical implementation* • Executing a company agreed EU filing strategy • Key points to consider when leading an EU Regulatory filing • Practical considerations when compiling the dossier

*Practical implementation for Case Study 1 will be done on Day 2 after hearing relevant presentation

The Organisation for Professionals in Regulatory Affairs

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