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RiskBenefits | riskbenefits.com Reviews
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RiskBenefits - Dr. John Clark
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RiskBenefits - Services
http://www.riskbenefits.com/Services.aspx
Signaling/Surveillance Consulting, Writing and Data Analysis. FDA Adverse Event Reporting System(AERS) Database. FDA Manufacturer and User Facility Device Experience(MAUDE) Database. Product and Event Grouping Methods. Educational Services and Seminars. RiskBenefits has participated in the design and conduct of safety specifications, routine and non-routine pharmacovigilance plans, and the development of RiskMAPs (risk minimization action plans) and REMS. Signaling and surveillance processes and document...
RiskBenefits Newsletter 2Q 2009
http://www.riskbenefits.com/2009%202Q%20WEB%20SITE%20RiskBenefits%20Newsletter%20Word%202003.htm
RiskBenefits Newsletter : 2Q 2009. NEW FDA SIGNALING AND SURVEILLANCE INITIATIVES. Within the last two years multiple initiatives have been launched by the Food and Drug Administration that have the potential to substantially change the way that the Agency and companies monitor healthcare products. Four of these programs are of particular interest: MedWATCH. Is to facilitate the intake of case reports from any source, whether arising from a consumer, healthcare practitioner, manufacturer or health care s...
RiskBenefits Newsletter 1Q 2009
http://www.riskbenefits.com/2009%201St%20WEB%20SITE%20RiskBenefits%20Newsletter%20Word%202003.htm
RiskBenefits Newsletter : 1Q 2009. NEW FDA SIGNALING AND SURVEILLANCE INITIATIVES. Http:/ www.hhs.gov/ocio/capitalplanning/exhibit300/FY09Exhibit300/fdamedwatchplus .html. The MedWATCHplus-FAERS-SPL superstructure will also function as a foundation for the receipt and analysis of electronic safety information from health care organizations (FDA’s Sentinel Initiative) which is mandated in the FDA Amendments Act of 2007 (FDAAA). Sentinel will allow safety signals that have been received and analyzed to...
RiskBenefits Newsletter 3Q 2009
http://www.riskbenefits.com/2009%203Q%20WEB%20SITE%20RiskBenefits%20Newsletter%20Word%202003.htm
RiskBenefits Newsletter : 3Q 2009. PRODUCT DICTIONARIES AND RxNORM. RiskBenefits Corporation is a consulting and data analysis company in the suburban Philadelphia area that provides safety signaling, surveillance, dictionary management, and pharmacovigilance services to the biopharmaceutical and medical device industries. RiskBenefits is owned and operated by John A. Clark, MD, MSPH, who has worked in the areas of biopharmaceutical pharmacovigilance and surveillance for over 20 years. Health care produc...
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Risk Management Performance Benchmarking
Risk Management Performance Benchmarking. Every year we spend billions of dollars on risk management – mostly without any real assessment of the effectiveness of those resources. How do you tell if the x million dollars spent last year on risk mitigation actually delivered benefit and/or reduced risk? How do we tell how an organization is performing against its peers in terms of ROI on risk mitigations? That's what this blog is about. Saturday, October 20, 2012. Why should we benchmark? Between us, we ha...
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