Presented by Joshua Sharlin
Thursday, November 16, 2017; 1:00pm – 1:45pm EST (GMT -5)
Legal staff on both sides of a medical product damage claim lawsuit must understand the collection and analysis of the safety data used to prepare the warning section of the product’s label. `
Regardless of whether you’re representing the plaintiff or defendant, you should be familiar with the process (and resulting documentation) FDA requires manufacturers to use in establishing evidence of a product’s safety.
On Thursday, November 16, 2017 at 1:00pm EST, join FOI as Joshua Sharlin, Ph.D., a recognized expert in FDA safety regulation and an experienced expert witness, offers a 45-minute audio presentation to provide an insider’s view of common problems and errors in adverse event reporting.
Following the session, Dr. Sharlin will remain available to answer any questions.
Topics to be Covered Include:
- How and why errors occur in adverse event reporting and who is responsible
- The eight job positions that have a role in the detection and reporting of adverse events
- The ten documents that contain information about adverse event reporting that you should request in discovery
- How knowledge of FDA’s required methodology for adverse event reporting can be used to read and understand documents that reveal adverse event reporting mistakes
- How to identify and use information needed to answer three key questions:
- What did the company know and when did they know it?
- What should the company have known and when should they have known it?
- What should the company have done and when should they have done it?
Who Should Attend:
All legal professionals involved in (or potentially involved in!) litigation regarding a medical device or pharmaceutical will benefit from learning about the documentation - available for discovery – required by FDA for safety claims.
About Your Instructor:
Joshua Sharlin, Ph.D., President of Sharlin Consulting, is a former FDA reviewer and has been deposed and testified in drug and medical device cases. For the last 20 years he has helped FDA-regulated companies of all sizes solve regulatory and compliance problems related to product safety and effectiveness. Over 50,000 people have attended his presentations on over 40 FDA-related technical and regulatory topics. If you have any questions about the content or coverage of the presentation, please ontact Dr. Sharlin directly at +1-410-231-8900 or email@example.com.
Try the Audio Package for $79. The package includes online delivery of an mp3 file of the entire presentation, including the question and answer session, as well as all of the handouts. (Please allow one week after the event date for delivery.)