CRED 8 Presentations

01/07/2024

 Developing and optimising your strategic plan – how to maximise the chances of an early approval

The Organisation for Professionals in Regulatory Affairs

3

Key messages

• Carefully consider available regulatory and scientific guidance • Request scientific advice as necessary (NB this should be requested before submitting the MAA = marketing authorisation application) • Ensure that the dossier is complete at time of submission  “Mature dossier”: importance of high quality and completeness of dossier  Early submission of a premature dossier will cause delay and might also lead to refusal! • Anticipate/prepare timely on possible comments

The Organisation for Professionals in Regulatory Affairs

4