ParagonRx to sponsor CHI's Post-Approval Drug Safety Strategies Forum
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| ParagonRx has a special registration discount for you. Click here! |
| Survey for Marketers |
Please take a minute to visit our survey on the effects of REMS on Marketing at Pharma Marketing Network, here.
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| REMS History |
A brief history of Risk Evaluation and Mitigation Strategies
[click here]
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| REMS Case Study |
Benefits of systematic failure analysis as part of successful REMS design
[click here]
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Dear Colleague,
The rising tide of public demand and regulatory requirements for patient safety is creating the need to implement Risk Evaluation and Mitigation Strategies (REMS) for medications; that, in the past, would never have raised questions about whether safety measures beyond labeling were required. The design of these REMS must address patient safety as priority #1, but it must also preserve patient access to the product. In our experience, a science-based approach is necessary to achieve this balanced outcome. For years, ParagonRx has relied on methods such as our proprietary Failure Modes and Effects Analysis program, RxFMEA®. We would like you to discover for yourself the obvious advantages of a science-based approach for your REMS and risk management programs. We hope you'll find the resources below valuable and worthwhile.
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 ParagonRx was pleased to host an invitation-only webinar to explore the parallels between successful risk management principles in the airline industry and the emerging principles in the pharmaceutical world. To view the full video, click here.
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Two new white papers posted on FMEA
- Effective Risk Management and Quality Improvement by Application of FMEA and Complementary Techniques [click here]
- Expert Evaluation of RxFMEA®
[click here]
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 FDA sent letters to manufacturers of certain opioid drug products on
February 6, 2009, indicating that these products will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits continue to outweigh their risks. View our public docket submission and our interim analysis that demonstrates how RxFMEA® can be successfully applied to the design of a robust class REMS program for long-acting opioids. [click here]
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We're committed to ongoing innovation to stay at the front edge of this expanding and evolving REMS discipline. We invite you to join in the process by contributing your inquiries, suggestions, and comments to me directly via email (jfetterman@paragonrx.com) or on our blog at blog.paragonrx.com.
Sincerely,
Jeff Fetterman
President |
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