Books / Publications
These textbooks cover the spectrum, from a theoretical framework underpinning the emerging discipline of risk management all the way to practical applications and approaches from some of the leading practitioners of pharmaceutical risk management today. We combine a discipline based on evidence-based methods, disease management principles, adult learning principles and continuous improvement with the practical experience of what works, what doesn't work, and how to successfully navigate the many uncertainties companies face when managing risk.
Currently available from the ParagonRx Book Store:
|A Framework for Pharmaceutical Risk Management||Purchase|
|Pharmaceutical Risk Management: Practical Applications||Purchase|
Ethnographic Research of IV Contrast Agent in Hospital CT Scanning Suites
Radiology Management, July/August 2010
“Ethnographic Research of IV Contrast Agent in Hospital CT Scanning Suites” by Blaise Hollot, PE and Kim Bullano, Pharm D (Radiology Management, July/August 2010) documents the behaviors and observations of nine hospital CT suites across the United States.
Read the article.
Expert tips for REMS success
FiercePharma Manufacturing - May 14, 2010
Start earlier than you plan to, challenge your own thinking, dig hard, and reach out to prescribers and patients. These tactics may be the keys to developing a successful risk evaluation and mitigation strategy (REMS), and to developing it as painlessly as possible.
Read the article.
REMS Metrics: Advice from ParagonRx
The RPM Report - RPM First Take - March 29, 2010
An excerpt from a webinar conducted by ParagonRx on January 13 discussing methods to assess Risk Evaluation & Mitigation Strategy programs. The main presenter was ParagonRx chief medical officer Gary Slatko. You can see the full article with a subscription to in The RPM Report.
Read the except at therpmreport.com.
Six surprising outcomes of FDA’s draft REMS guidance
Dr. Gary Slatko of risk-management support provider ParagonRx outlines six interesting developments to arise out of FDA’s first draft guidance for industry on Risk Evaluation and Mitigation Strategies.
Read the full article at PharmaLive.com.
GAO Accuses FDA of Tardy Trial Data
Pharmaceutical Executive Online - October 28, 2009
The US Government Accountability Office (GAO) on [October 26, 2009] released a 71-page report citing FDA for taking too long to review postmarket trials of drugs through its expedited approval process.
Read the full article, including quotes from ParagonRx's Dr. Gary Slatko, at pharmexec.findpharma.com.
Download the Government Accountability Office Report
Risk Evaluation and Mitigation Strategies - REMS Take Hold
Pharma Voice - September 2009 Download
The new legislation surrounding tougher REMS requirements is expected to effect marketing as well as drug development – but the impact might not be all bad.