Robert Seevers, Senior Advisor at Pearl Pathways, will lead the RAPS Indiana Chapter webcast on Thursday, April 30.
Robert Seevers, PhD
Session description: Eat your lunch and join the RAPS Indiana Chapter online for tips and tricks on how to build a positive relationship with Food and Drug Administration (FDA) scientists. In working with FDA reviewers, it is common sense to avoid doing anything to annoy, frustrate or anger them. However, many submitters do so unwittingly. This session will identify the common causes of exasperation among reviewers and offer effective recommendations for avoiding them. Topics to be covered include how not to pose questions that require a reviewer to review a large amount of material twice, proper use of FDA guidance documents, when to disclose a problem to regulators and best practices for direct telephone and email contact.
The Lunch and Learn webcast will run from 12:00 – 1:00pm EDT, and RAC holders may claim one RAC recertification credit.
Learn more about the RAPS Indiana Chapter and keep up to date on future events by visiting their website.