The pharmaceutical industry has become a favorite “bad guy” among the public, media, and legislators. There is a perception that the many risks of medications is proof that the industry does not care about the safety of patients. Nonsense. (more…)
Posts Tagged ‘drug safety’
No Free Lunch: An Intuitive Approach to Benefit-Risk Management
Tuesday, November 16th, 2010Pharmacovigilance, Benefit-Risk Roadmap Topic of the ParagonRx Wednesday Webinar
Tuesday, November 9th, 2010In response to the explosion of regulatory guidances, many pharmaceutical companies have established new processes and structure for pharmacovigilance and benefit-risk management. However, the problem is that the training and competencies of those who have traditionally filled these roles may not be adequate to meet the new challenges.
This issue of core competencies and who will fulfill them will be addressed in a ParagonRx free webinar which will take place this Wednesday, November 10, at 12 noon Eastern Time. (more…)
Grounding Your REMS in a Science-Based Approach – The ParagonRx RxFMEA® Approach to Assessing Medication-Use Risk
Wednesday, April 7th, 2010In 2001, ParagonRx first employed the science-based risk assessment methodology Failure Mode and Effect Analysis (FMEA) to proactively assess patient safety in the emerging field of Pharmaceutical Risk Management. While a novel approach for assessing drug safety issues, FMEA has a long history in other risk intensive industries used to mitigate process and design failures, including the aerospace, military, nuclear, and even pharmaceutical manufacturing. Research into how FMEA was used to mitigate risks across other industries and references made in FDA Draft RiskMAP Guidance, provided the rational for applying FMEA to pharmaceutical product and patient safety. RxFMEA®, ParagonRx’s proprietary adaption of the FMEA process, applies the principles of process mapping complex systems and systematically evaluating a process for potential failures. RxFMEA® is a proactive, bottom-up assessment that identifies the behavioral causes of medication use failures and prioritizes interventional opportunities to mitigate adverse events. RxFMEA® was specifically designed as a Pharmaceutical Risk Management tool and is now utilized in REMS development for the pharmaceutical and biotech industries. (more…)
