CRED Project Management for Regulatory Affairs Professionals

Stage 1: Define the Project

Project P’s Problem

Divergencies in the registered indications and shelf-life across several EU markets. TOPREXA – aiming for identical indications, ADRs and shelf- life across the 12 Member States (MS) Safety and confidence in the product through harmonised labelling. Increase in shelf life, patient exposure

Product/service/outcome

Purpose

Process

Comparison of SmPC/Module 2.3 and 3 Current tenders and pricing Available stability data

People

Refer to Stakeholder Slide

Politics

Company position, Commercial, Local requirements, Tenders, Pricing CHMP, National Competent Authorities, Company Senior Management Resource (people and subsequent submissions), Impact on other markets (labelling dependencies)

Power

Pounds

Priorities

Supply to patients, Timelines, Label