How to do Post-Approval Registry Studies for Medical Devices

Why should you take this eConference?
-  Because we are living in an age of "evidence-based medicine."
-  Because FDA is putting more emphasis on registry studies and starting to mandate them.
-  Because insurance companies won't cover new technologies unless you can document them as safe as the predicate device.

Objective:
To look at registry studies from the two different perspectives of implementation and review; and to introduce the new AHRQ Registry Handbook at http://effectivehealthcare.ahrq.gov/decide/registryDraft.cfm.

Description:
Registries are used by companies for internal tracking of utilization and outcomes. In this eConference you will learn the following: the purpose and current uses of registry studies; how to plan, implement, and manage registry studies; the potential ways medical devices are followed after FDA approval; and why the time period after FDA approval is as important as obtaining FDA approval itself.

Implementation issues will be discussed by Dr. John Pandolfino, an experienced investigator and IRB co-chair. Review issues will be discussed by Dr. Elise Berliner, a member of AHRQ who provides scientific input to CMS. The eConference will be moderated by Anne Marie Murphy, whose legal practice deals with the day-to-day issues of medical devices.

You will receive:
-  Recording of the presentation.
-  Acrobat file of Dr. Pandolfino's slides on implementation.
-  An Acrobat file of Dr. Berliner's slides on review.
-  CEUs

Who should attend:
-   Anyone involved with or concerned about planning, implementing, or managing registry studies or other post-market surveillance activities.
-   Marketing people concerned with obtaining reimbursement for new product introductions.

Speakers:

Anne Marie Murphy, Attorney with the law firm of Hyman, Phelps & McNamara, P.C. in Washington, D.C.
Ms. Murphy's practice is focused primarily on prescription drug and medical device issues, with a particular interest in federal regulation of clinical trials. Prior to pursuing her legal education, Ms. Murphy worked in a clinical microbiology laboratory, and then entered the pharmaceutical industry. She was employed by Wyeth-Ayerst Research to conduct quality assurance audits of clinical trials. Ms. Murphy received her B.S. degree in Medical Technology, magna cum laude, from Wesley College and her J.D., summa cum laude, from Widener University School of Law. Ms. Murphy can be contacted through www.hpm.com or via email at amurphy@hpm.com

Dr. John Pandolfino MD, MSCI, Assistant Professor of Medicine at the Feinberg School of Medicine of Northwestern University in Chicago, IL. Pandolfino's career is focused on clinical and physiologic research with 75% of his time spent on research and 25% on clinical duties. Dr. Pandolfino has been actively involved in medical device development in GI diagnostics and therapies and is also the Vice-Chair of the Investigational Review Board Panel at Northwestern University. Dr. Pandolfino can be reached at j- pandolfino@northwestern.edu

Elise Berliner, Ph.D., Director, Technology Assessment Program, Center for Outcomes & Evidence, Agency for Healthcare Research & Quality/Centers for Medicare and Medicaid Services. The Technology Assessment program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions and other policy issues. Prior to joining AHRQ, Dr. Berliner worked as a consultant to pharmaceutical and medical device companies on cost-effectiveness and outcomes research, technology assessment and reimbursement planning. Dr. Berliner also has several years of experience in research and development at a number of innovative medical technology companies. She was a Congressional Fellow at the Office of Technology Assessment. Dr. Berliner received her Ph.D. in biophysics from Brandeis University.

The purchase is $495 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.2 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.