REMS Assessment Design and Protocol Tackling the #1 Misunderstood REMS Requirement
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It’s the #1 concern of every drugmaker expected to create a REMS. How do you go about preparing the required REMS assessment?
The purpose of the assessment is crystal clear. Required in the final guidance from September 2009, the assessments are designed to measure effectiveness, to ensure patient safety and also to prove to the FDA that it has achieved its goal to reduce drug risks.
But from there, things start to get murky. The final REMS guidance simply does NOT say how to proceed with creating an assessment.
And with many REMS assessments coming due this year, yours is likely to be among them.
So it’s understandable if — even with the clock ticking — you’re still not sure what to do. But it’s not too late. There is a way to find out.
Sign up to attend REMS Assessment Design and Protocol, the FDAnews webinar that’s set for Tuesday, February 23, 2010 — and then listen in as assessment expert Larry Risen addresses the top
6 challenges facing the pharmaceutical industry in the design and preparation of a REMS assessment.
- What are the steps to create a REMS assessment and what is an acceptable measurement tool?
- How does the FDA expect manufacturers to measure patient recruitment and assessment?
- What methods are practical and acceptable to recruit and assess prescribers?
- What is a valid and reliable sample size?
- How do manufacturers minimize sample bias?
- How do we use the data collected to predict the effectiveness of the REMS program?
At the end of this 90-minute webinar, attendees will know what the FDA will be looking for from a REMS assessment, what the FDA has been asking companies that have already begun completing assessments and what is a good timeline to fit all of the missing pieces together.
Plainly put, you won’t find start-to-finish, fully vetted REMS assessment details like this anywhere else. So mark your calendar now for REMS Assessment Design and Protocol on Tuesday, Feb. 23 and — from the convenience of your own computer screen — you’ll discover:
- 4 elements that should be evaluated to measure the effectiveness of a medication guide assessment
- When to use a stakeholder survey vs. a pharmacoepidemiologic study — and when you need to use both
- 7 important questions you must ask to complete a successful health care provider survey
- An effective way to gather a reliable prediction of actual market behavior
- The appropriate stakeholder recruitment strategies to ensure a successful assessment
- What the smallest sample size possible is to assure statistical considerations — and still meet FDA expectations!
- 5 keys to creating good survey content — covers question type, medium used, and performance thresholds
- How soon you need to start collecting survey data — critical if you want to hit the mandatory 18 month mark
- And more...
Mr. Risen will even reveal actual questions the agency is now asking of companies already working through the process — your best chance for predicting whether or not the FDA will deem your REMS program effective.
And the best part? You can attend REMS Assessment Design and Protocol without ever leaving your workplace. Just make sure you're in front of a screen at the appointed time.
Everyone in your organization with a role in REMS deserves to take part in this event — and they can do so, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.
Have questions? Simply submit them via email for answers by the time the session ends.
You’ll finish this fast-paced session knowing precisely what the FDA wants to see from your REMS ... the timeline you need to follow ... keys to effective design, preparation, protocol and more.
Don’t delay — plan now to attend this valuable, virtual workshop on Tuesday, Feb. 23.