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
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