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Survey began 10 August 2009

This survey solicits your opinion on the impact of REMS on pharma marketing.

Take the survey here.

See Resources & Further Reading below...

Background

Risk management. REMS (Risk Evaluation and Mitigation Strategy). Danger management of your product's life cycle.

These topics are all crucial to brand managers and marketing executives. Did you know that a Risk Evaluation and Mitigation Strategy (REMS) can be a win-win-win situation for you, your product, and the patient? Or that the longer you wait in the product development process to start thinking about REMS, the more you will lose control of your product's future?

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS.

Pharma Marketing News in association with ParagonRx invites you to take the following 5-minute survey because we want to know what you think about these issues.

"ParagonRx has been a leader in developing the field of risk management since its founding in 2001, and we got that way by listening to patients, physicians, marketers and safety experts and by doing our homework," says Jeff Fetterman, President and CEO of ParagonRx. "In fact, we helped write the book on REMS - two of them in fact in cooperation with the Food & Drug Law Institute. We know the design and implementation of REMS is a multi-disciplinary effort that requires the leadership of marketers to create the right customer experience with the REMS. We’re eager to work together with you."

Survey questions include:

• After product launch, what role do you think marketing should play in assessing REMS effectiveness?
• In your future Direct-to-Consumer marketing, how important will REMS be in changing your marketing strategy?
• In light of REMS, how often do you plan to use the following communication channels in your marketing strategy?
• What are the three most important ways the FDA could improve patient safety?
• Others...

Please take 2 minutes to answer this survey relating to Impact of REMS on pharma marketing. The first 10 respondents who complete the entire survey and provide contact information will be eligible to receive a $25 Amazon.com Gift Card. Take the survey here.

You will be able to see a summary of up-to-date de-identified results upon completion of the survey.

Results of this survey may be summarized in an issue of Pharma Marketing News.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.