Description: The pace of innovation and change in medicinal product development is increasing as are changes in regulatory frameworks and standards. Maintaining awareness of these regulatory changes and providing strategic input into product development teams are critical deliverables of modern regulatory intelligence (RI) programs yet little information is available on how to setup the processes & tools for a new RI program.
Whether you are a dedicated RI program manager or perform RI activities as part of another role, this hands-on workshop will provide students with the opportunity to leveraging the tools and practice the techniques needed to start an RI program from scratch using simple processes and freely available tools and databases such as Google search, Feedly, Excel, Outlook, ClinicalTrials.gov, Drugs@FDA, and others.
Preconference workshops require a separate registration fee and are not included in main conference registration
Learning Objectives:
Describe the parts of a modern RI program needed for a biopharmaceutical or medical device organization.
Setup and manage tools and processes for surveilling the external regulatory environment including: monitoring external news & regulatory changes, screening & triaging relevant news for your organization, and reporting relevant news to your internal stakeholders.
Set up and manage tools and process for conducting ad hoc requests for precedent searches including: clarifying & triaging incoming requests, conducting searches of publicly available information, and reporting findings to the requestor and other stakeholders.