Mastering IVD Clinical Trials: Regulatory Issues

This eConference is the fourth in a four-part series presented by renowned experts Dr. Cheryl Hayden and Dr. Robert Thiel.  

 

Why should I take this eConference:
Attendees of this conference will learn how to preempt common problems that arise in interactions with the FDA relating to IVD clinical trials. This could save time and money in both trial conduct and regulatory issues.

Who should attend:
Anyone who will be involved in IVD clinical trial design and management, such as:
- Regulatory personnel
- Project managers
- R&D personnel
- Senior management

You will receive:
- Slides
- examples of FDA guidelines
- a guide to finding useful information on the FDA website
- An expert speaker
- A chance to listen to other's QnA
- CEUs & Certificate

Presenter:
Clinical Device Group is proud to present Dr. Cheryl Hayden and Dr. Robert P. Thiel.

Dr. Cheryl Hayden. Dr. Hayden has degrees in medical technology, biostatistics, and microbiology. She has worked for 25 years in the field of clinical research, 8 years in a consulting capacity. Much of her experience is with in vitro diagnostics. She was involved in early work with tumor markers, determining the utility of these assays and raising awareness of their use in the oncology community. She has published several papers on trial design for IVDs, specifically on nested endpoints and flaws of gold standards. Dr. Hayden’s interest in IVD trial design stems from her early training in medical technology. Dr. Hayden can be reached at Cheryl.hayden@comcast.net.

Dr. Thiel has degrees in physics, clinical counseling and psychometrics. He is an expert in the analysis of IVD data for the Medical Device Industry with more than 75 510K and 5 PMA approvals. He has published papers in the area of free PSA, breast cancer, ovarian cancer, liver disease and multivariate analyses as applied to sports (baseball and basketball). His current interests lie in the area of bootstrap and permutation test methodology and the application of these methods to small sample trials. Dr. Thiel can be contacted at rpthiel@thielstatcon.com.

The purchase is $403 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.25 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.