This ISMPP U Webinar will focus on publication planning in the diagnostics space. We will explore the regulatory process in the US for diagnostics test and how it differs from the traditional pharmaceutical therapeutic pathway. Major differences in publication planning, data availability, strategy, and publication timing for diagnostics will be highlighted and contrasted with the typically approach used for publication planning with pharmaceutical therapies.
The faculty will also present real-world examples of best practices in publication planning and execution for a diagnostic product (aka “a day in the life of a Publication Lead”).
At the end of this session, participants should be able to:
- Understand the regulatory pathways for diagnostic test US market approval
- Understand how pharmaceutical therapy publication best practices can be adapted to the diagnostics space
- Identify at least 3 differences in strategic publication planning for diagnostic products compared to strategic publication planning for pharmaceutical therapies