Module 1 2021

25/06/2021

Caveat 1: Do you have a global product strategy?

• The maximum reuse of content is only possible when the product strategy is global • There may be good reasons for regional differences ─ Different regional guidance for the disease ─ Business decisions on partnering and licensing ─ Business decisions on sourcing and manufacture • But try to avoid internal issues leading to regionally different content ─ Aim to write global overviews and summaries ─ Publish documents in a way that allows global reuse (particularly CSRs)

The Organisation for Professionals in Regulatory Affairs

33

• The strategy points discussed here work best for the first submission of the initial Marketing Authorisation in each of the countries ─ Or at the start of any new variation/supplement • This is the one time you can control the content and choose to keep it as harmonised as possible • Thereafter the review processes and timelines, the preferences and foibles of each reviewing agency and the internal priorities will take over • However, continue to look for the opportunities to create and reuse common content Caveat 2: Product lifecycle grows differently in each region

The Organisation for Professionals in Regulatory Affairs

34

17