December 9, 2009

Patient Registries: Integrating New Requirements and Evolving Best Practices

Building a smart patient registry can improve regulatory compliance. But it can also be good for business. Find out just how good when you participate in this webinar that will help you better understand how registries can enhance the connection you have with your patients and providers.

With the number of patient registries on the rise in recent years, pharma and device companies are clamoring for better guidance on how to design and conduct them. While these registries don’t have the kind of impact that restricted distribution or large clinical trials can, the FDA still sees them as critical to helping answer important product safety questions.

FDA’s post-marketing requirements are getting more and more complex. With new techniques, such as risk evaluation and mitigation strategies, FDA is requiring more from traditional products, including patient registries.

If FDA requires one of these registries for your product—and the regulatory threshold has never been lower—you'll need a better understanding of the new registry standards to make sure you can market your product the way you want. Whether you’re looking to get a drug approved or simply increasing revenue from one that’s already on the market, you can’t afford to miss this Windhover Webinar on patient registries that will help you understand the changing environment so you can be ready if FDA comes calling.

So what is the best way to conduct a registry?

As of today, there's no formal FDA guidance for establishing registries outside of a pregnant population. The Agency for Healthcare Research and Quality does provide general guidance in its User's Guide to Registries, which it’s in the process of updating. Until that’s completed, you can still get the insights you need from our panel of experts to better understand the product's potential for your business.

Join The Pink Sheet and Windhover Webinars for Patient Registries: Integrating New Requirements and Evolving Best Practices. Then listen as our experts provide you with tips and techniques to help you design a registry for maximum value.

Whether you’ve already created a patient registry or want to know how to begin, this is the webinar for you.

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our panelists when we open up the phone lines for live Q&A.

Here’s just some of what you’ll learn during this comprehensive 90-minute webinar:

• How to avoid early recruitment troubles and maximize patient retention
• The right amount of information to collect—and how to avoid collecting too much or too little
• How to make sure the data is clinically relevant
• Why registries are increasing—and how they will change the way you promote your products
• How registries can improve your understanding of your product's safety profile
• The best way to structure governance of a registry and its data.
• How to link registries with electronic medical records for maximum impact
• When to end a patient registry

SPEAKERS

	Landen Bain is a freelance expert in data standards for healthcare and clinical research. As liaison between CDISC, the clinical research standards body, and the healthcare-information community, he bridges two worlds that have common interests and common subjects but little interaction. During his tenure on the CDISC board, Mr. Bain helped restructure the relationship between CDISC and HL7, launching the model-development process that became the BRIDG, a semantic model of clinical research adopted by CDISC, HL7 and NCI. He originated the CDISC Single Source project, which re-visions data capture for healthcare and clinical research as a single integrated process. Mr. Bain works with pharmaceutical and biotech companies, technology vendors and healthcare providers to develop pilot implementations of the Single Source concept. He has written a proposed profile for IHE, which will promulgate standard interactions between Electronic Health Record systems and appropriate application within the clinical development domain. Mr. Bain also co-chaired HL7’s board-appointed Marketing Committee, and helped to coordinate the joint IHE/HL7 interoperability demonstration at HIMSS 2004. He served for more than 20 years as Chief Information Officer at Duke University Health System and Ohio State University Hospitals. During his tenure at Duke, he played an instrumental role in developing and promulgating the Clinical Context Object Workgroup (CCOW), ushering CCOW forward as a national standard and a widely used enabling technology. He is a charter member of the College of Healthcare Information Executives.
	Dr. Richard Gliklich is President of Outcome, providing patient registries, studies, and technologies for evaluating real-world outcomes. He does clinical research on effectiveness, safety and quality of care. Dr. Gliklich was principal investigator and senior editor of the U.S. Agency for Healthcare Research and Quality (AHRQ) handbook, Registries for Evaluating Patient Outcomes: A User’s Guide. The programs developed by Dr. Gliklich include the American Heart Association’s “Get With the Guidelines®” registries in cardiovascular disease, heart failure, and stroke, which involve more than 2,500 U.S. hospitals and more than one million patients. Dr. Gliklich is the director of an annual international conference at Harvard, focusing on post-approval studies, registries and risk management (Post-Approval Summit®). He is the editor of a textbook on the practical value of real-world clinical data in medical practice, Profiting from Quality: Outcomes strategies for medical practice, published by Jossey-Bass. He is also a Principal Investigator (PI) for the Outcome DEcIDE Center, one of 13 DEcIDE centers under the Agency for Healthcare Research and Quality’s Effective Healthcare Program. Dr. Gliklich received the 2004 Innovation Award from the U.S. Department of Health and Human Services and the 2007 eHealth Initiative Award. In addition to his work at Outcome, Dr. Gliklich is a practicing physician and an Associate Professor at Harvard Medical School.
	Joanna Haas MD, MS, is Vice President, Genzyme Global Patient Safety and Risk Management.  She has broad experience in drug development, pharmacovigilance and safety risk management in Europe and the United States. She holds specialty certification in internal medicine and preventive medicine and is a Fellow of the International Society for Pharmacoepidemiology.

REGISTRATION

• Register online: Click here for the live webinar
• Register online: Click here for the live webinar PLUS recording
• Buy the recording: Click here for just the recorded webinar
• Register by email: custcare@elsevier.com
• Register by phone: 1 (800) 332-2181 (U.S.) / +1 (908) 547-2159 (non- U.S.)

WEBINAR DETAILS

DATE: December 9, 2009
TIME: 2 PM ET
DURATION: 90 Minutes

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