CRED 8 Presentations

01/07/2024

 Learning Outcomes: Recap

The Organisation for Professionals in Regulatory Affairs

55

Learning Outcomes: Recap

 Developing and optimising your strategic plan – how to maximise the chances of an early approval  Scientific advice and its impact on a successful application  Validation, responses to questions and end of procedure – best practice advice/Real-life procedure timings – where time can be lost in a procedure

 Typical dossier deficiencies and how to avoid these  Common pitfalls (both practical and strategic)

 Talking to regulatory agencies  Optimisingappeals and hearings

The Organisation for Professionals in Regulatory Affairs

56