FDA Draft REMS Guidance - Implications and Opportunities for REMS Lifecycle Management

While there has been progress regarding REMS in the form of Draft Guidance from the FDA in 2009, there remains much to be done - by both FDA and industry.  The pharmaceutical industry needs to be proactive in its advocacy for making pharmaceutical risk management a credible scientific discipline.  Companies must be prepared to design, implement, monitor, and manage the lifecycle of REMS programs.

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Top Six Educational Principles for Designing an Effective REMS

FDA now expects pharmaceutical companies to measure and track the effectiveness of REMS programs. This requires educational techniques that achieve unprecedented levels of effectiveness and behavior change.

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Writing a Dear Healthcare Professional Letter

A Dear Healthcare Professional (HCP) Letter is a risk communication tool that is often included as an element of a Risk Evaluation and Mitigation Strategy (REMS) Communication Plan.  This article provides some guidance for developing a Dear HCP Letter.

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Ten Things to Consider When Developing a REMS

Ten of the most important considerations to take into account when developing a REMS:
1. Patient Safety First
2. Create Options
3. Co-design with Stakeholders
4. Use Science-Based Approaches

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Effective Patient Education for REMS Programs

In today’s health care landscape, physicians are an important influencer of patient behavior, and patient adherence to therapy is critical to achieving risk management program outcomes. The effective education of physicians in a manner that leads to improved patient adherence is more important than ever.

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Coordinating Risk Evaluation and Mitigation Strategy (REMS) Activities

Coordinating REMS activities between functional groups can be a challenging task.  How do you coordinate the multitude of activities prior to REMS submission to the FDA?   Since REMS is a relatively new FDA initiative, most companies do not have a single group charged with preparing the REMS document. Instead, a multifunctional team effort is needed...

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REMS Performance Assessments: The Common Element to REMS

Regardless of what program elements go into your REMS, it’s going to need an assessment plan to evaluate program performance. So, why does FDA require an assessment plan and what does it need to consist of?

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