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Wed - Dec 9, 2009 @ 01:00 PM CST Ended
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Patient Registries: Integrating New Requirements and Evolving Best Practices

(www.windhover.com)

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.

Tags

  • FDA, medical, health, healtcare, patients

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