Are the risk mitigation measures within a REMS (Risk Evaluation and Mitigation Strategy) adequate enough to ensure optimal benefit-risk management? Even if the FDA doesn’t require a REMS for a product, does it make sense to undertake risk management measures anyway? Read the rest of this entry »
Complimentary Webinar to Address: Is a ‘Voluntary REMS’ a Good Risk?
by Kevin Fetterman
April 11th, 2011
ParagonRx Webinar to Provide Guidance On FDA Draft Guidance for MedGuides in REMS
by admin
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A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).
“Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will take place Wednesday, March 9, at 12 noon Eastern Time.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. Read the rest of this entry »
REMS 2010: A Year in Review
by ParagonRx
December 3rd, 2010
As the pharmaceutical community looks forward to the issuance of the new FDA Risk Evaluation & Mitigation Strategies (REMS) guidance in 2011, a free webinar will examine all the REMS occurrences during the past year and what they will portend for the future. Read the rest of this entry »
No Free Lunch: An Intuitive Approach to Benefit-Risk Management
by Jeff Fetterman
November 16th, 2010
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. Read the rest of this entry »
Pharmacovigilance, Benefit-Risk Roadmap Topic of the ParagonRx Wednesday Webinar
by ParagonRx
November 9th, 2010
In 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. Read the rest of this entry »
Hot Topics in Assessing REMS Examined In ParagonRx October Wednesday FoREMS Webinar
by ParagonRx
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. Read the rest of this entry »
Computed Tomography (CT) Imaging Ethnography
by ParagonRx
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. Read the rest of this entry »
Ethnographic Research and REMS
by admin
July 12th, 2010
-Guest Blog by Andrea J. Simon, PhD.-
In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol is becoming more and more important; i.e., when a drug is in widespread use, risks need to be better understood. At the same time, there is a growing sense of uncertainty around ethnography’s legitimate role, how to integrate it into quantitative research, and when to use its information and insights to support or alter a previously defined direction. Along with this greater scrutiny, there is rising debate about ‘best practices’ in observational research processes, especially regarding the need to define protocols to ensure that research is conducted with proper rigor and is producing suitable, credible results. Read the rest of this entry »
REMS Assessments: Designing and Evaluating REMS
by Karen Lenoir
May 26th, 2010
Sponsors are struggling with how to adapt research survey methods to meet the regulatory reporting standards of REMS assessments. Assessments need to be designed in a way that measure risk mitigation. Reports and interpretation of findings are highly qualitative and declarations of success may be inconsistent with those findings.
REMS assessments should be designed in a meaningful manner for measuring specific objectives. It’s important to start with a rational design – balance the interests of regulators, customers, and manufacturers. The design should be evidence-based and include end users in the design process. Read the rest of this entry »
REMS Assessments: Insights and Strategies for a Successful Survey Program
by Karen Lenoir
May 12th, 2010
REMS Assessments are now the hot topic in REMS. We’ve reached the 18-month mark and it’s not a coincidence that Draft Guidance includes a section on assessments and modifications. Companies need to begin to contemplate not just how to analyze and interpret their assessment findings, but they need to think about the best way to actually evaluate their REMS performance. Read the rest of this entry »
