CRED 8 Presentations

01/07/2024

CRED Navigating European Regulatory Procedures – 9-10 July 2024

Agency perspective on strategic and practical

considerations – how to work effectively with regulators

Kora Doorduyn-van der Stoep; EU-representative at the MEB Medicines Evaluation Board in The Netherlands

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

 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  Optimising appeals and hearings

The Organisation for Professionals in Regulatory Affairs

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