Archive for the ‘Tweets’ Category

ParagonRx Webinar to Provide Guidance On FDA Draft Guidance for MedGuides in REMS

Friday, March 4th, 2011

A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).

“Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will take place Wednesday, March 9, at 12 noon Eastern Time.  The topic is the latest in a series of monthly “Wednesday FoREMS” webinars sponsored by ParagonRx, an inVentiv Health company, pioneering expertise in REMS and Benefit-Risk Management. (more…)

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Hot Topics in Assessing REMS Examined In ParagonRx October Wednesday FoREMS Webinar

Monday, October 11th, 2010

Of the 146 FDA REMS programs approved to date, 41 of them – almost one-third – have already been modified. Undoubtedly, REMS assessment findings have played a role. In addition, new insights arising from FDA comments influence the design of future assessments. These topics will be the focus of a free webinar hosted by ParagonRx which will take place this Wednesday, October 13, at 12 noon Eastern Time. (more…)

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Computed Tomography (CT) Imaging Ethnography

Wednesday, September 29th, 2010

Computed Tomography (CT) diagnostic scans are performed on thousands of patients daily throughout the world.  CT scanning suites are under multiple pressures to optimize their process and improve their financial situations.  The diagnostic value of certain scans can be enhanced by the use of intravenous iodinated contrast agents (IVCA) as they allow for increased anatomical visualization.  A supplier of IVCAs contacted ParagonRx to map the administration of these agents to help identify ways to help optimize suite operation. (more…)

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REMS Coordination Office

Monday, April 26th, 2010

The REMS Coordination Office (RCO) is the organizing hub among a Sponsor’s cross-functional team. The RCO is responsible for coordinating and tracking various aspects of REMS and the activities of outside service providers. The RCO features a core team of individuals tasked with managing REMS activities and processes.

This was the topic of a recent webinar hosted by ParagonRx. Jeff Fetterman, ParagonRx President, opened the webinar by borrowing two examples from the nuclear industry to illustrate how two different principles for organizing operational processes and systems have the potential for two different outcomes – flawless or disastrous. (more…)

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