CRED Project Management for Regulatory Affairs Professionals

Work Breakdown Structure

Medical Writing Provide Support CSRs

Clinical Sub Team Meeting

Senior Mgmt Approval

Author CO Addendum

Safety Conducts SB and Literature Search

Author Safety Report to support ADRs

Safety Sub Team Meeting

Update EU Nat Labels

Senior Mgmt Approval

Update EN Labels

KO Meeting to discuss CHMP Q’s

Publishing

CMC Assess Current Available Stability Data

Update Relevant M3 Sections

Author Cover Letter

Author Response Document to CHMP Questions