CRED 8 Presentations

01/07/2024

Probability of success

• Centralised • “All or nothing” but majority decision when consensus not reached • Decentralised • Choose RMS and CMS but can no longer withdraw in stage 2 to avoid arbitration/referral • No consensus = referral

The Organisation for Professionals in Regulatory Affairs

13

Internal factors – specific to procedural choice

• How does your choice of EU procedure impact the global strategy? • Company infrastructure/level of experience • Effective and Robust Planning • DCP/MRP ‘slot’ / Letter of Intent • Meetings (Scientific Advice / Pre-submission meetings / etc) • Document preparation • eCTD publishing & assessment activities

The Organisation for Professionals in Regulatory Affairs

14