Director, Head of Global Regulatory Policy & Intelligence Seattle Genetics
Description: Finding and analyzing public information from global health authorities is a core activity of regulatory professionals. Whether you’re looking for regulations and guidance or product approvals and enforcement actions, the availability of public information can be overwhelming and confusing even for seasoned professionals. Although vendors can make some of this information easier to locate, the underlying policies and technologies that enable vendor solutions are important to understand. This session will discuss the landscape of global regulatory agencies and their transparency initiatives, especially the accessibility of online information in the age of internet search engines. This session will also include a review of the transparency differences between major health authorities like FDA and EMA and their regional counterparts around the world.
Learning Objectives:
Find and locate agency information with greater awareness of the role transparency initiatives play
More confidently communicate with your stakeholders when information they want is not made public by the agencies
Better evaluate proposals and quotes they receive from regulatory database vendors
