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September 26, 2013

President of ParagonRx, an inVentiv Health company, Offers Insights on Risk Management Standards at Brookings Institution


Jeffrey Fetterman Presents RxFMEA® as a Standardized Method to Assess and Minimize the Risks of Using Medications at Event Held on Behalf of FDA

NEWARK, DELAWARE – September 26, 2013 – Jeffrey Fetterman, president of ParagonRx,

an inVentiv Health company offering risk management programs to enhance product safety, told an audience of risk experts at Brookings Institution on Wednesday that more rigorous risk management systems are badly needed in the pharmaceutical sector.

The workshop, Strengthening Risk Evaluation and Mitigation Strategies (REMS) through Systematic Analysis and Evidence-Based Assessment, was convened by Brookings on behalf of the U.S. Food and Drug Administration (FDA).

As a recognized expert in the risk management field, Fetterman participated in the session on Systematic Approaches for Standardizing REMS Design.  During the session, he discussed the value of RxFMEA®, a risk assessment methodology.   The methodology developed by ParagonRX and adapted from Failure Mode and Effects Analysis breaks down medication use into process and sub-process steps.  These steps are then analyzed to identify points of weakness, the cause for each weakness, the potential risk to patients, and the tools needed to mitigate risks at each stage.

“Too many risk evaluation and mitigation strategies are still being designed using ad hoc or intuitive methods,” Fetterman warned. “Where patient safety is concerned, a more rigorous and systematic method for risk management is long overdue.”

The workshop was arranged to explore potential frameworks for standardizing REMS design, as well as the implications of adopting standardized approaches to developing, implementing and assessing REMS. Fetterman previously presented his ideas at a public meeting the FDA hosted in July to gather stakeholder feedback on REMS standardization.

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the resources to maintain a review process for human drug and biologic products, the FDA is required to explore strategies to standardize REMS with the goal of reducing the burden of its implementation on practitioners, patients, and others in various healthcare settings.


About ParagonRX, an inVentiv Health company

ParagonRx provides product safety risk management and healthcare systems consulting to pharmaceutical and medical device companies. The company guides clients through proactive planning across the life cycle of products with REMS, RMPs, and post-marketing/ authorization commitments. Its benefit-risk management expertise, systematic methodologies, and standardized tools, combined with the unique suite of services available through the inVentiv Health network, improve patient safety and enable the commercial success of clients’ brands. For more information, visit

About inVentiv Health
inVentiv Health, Inc. is a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. inVentiv offers convergent services that deliver extraordinary outcomes to clients whose goal is improving human life. In 40 countries around the world, inVentiv’s 12,000 employees help clients rapidly transform promising ideas into commercial reality. inVentiv clients include more than 550 pharmaceutical, biotech and life sciences companies, as well as companies that now see health as part of their mission. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. For more information, visit


Jenna Sisler


inVentiv Health, Inc.

+1 302 444 9850

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