Books / Publications
Books
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 |
Publications
Six surprising outcomes of FDA’s draft REMS guidance
Med Ad News - November 2009
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Slatko of risk-management support provider ParagonRx outlines six interesting developments to arise out of FDA’s first draft guidance for industry on Risk Evaluation and Mitigation Strategies.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.
