Posts Tagged ‘ParagonRx’
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A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).
“Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will take place Wednesday, March 9, at 12 noon Eastern Time.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…)
Tags: benefit-risk, FDA Guidance, FDAAA, medication guide, ParagonRx, REMS, REMS design, Risk Evaluation and Mitigation Strategy, risk management
Posted in FDA Guidance, REMS, Tweets, Webinar | No Comments »
Friday, 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. (more…)
Tags: approved REMS, communication plan, Elements to Assure Safe Use, FDA, FDA Guidance, FDAAA, medication guide, ParagonRx, REMS, REMS guidance, Risk Evaluation and Mitigation Strategy, webinar
Posted in FDA Guidance, REMS, Webinar | No Comments »
Tuesday, 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. (more…)
Tags: appropriate use, benefit, benefit-risk management, drug safety, Jeff Fetterman, medication use, ParagonRx, patient safety, pharmaceutical, REMS, risk, safety
Posted in Appropriate Use, Pharmaceuticals, REMS | No Comments »
Tuesday, 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. (more…)
Tags: benefit-risk, benefit-risk management, drug safety, ParagonRx, pharmacovigilance, REMS, risk management, risk management professionals, safety
Posted in REMS | No Comments »
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…)
Tags: approved REMS, FDA Guidance, ParagonRx, REMS, REMS effectiveness, risk assessment, Risk Evaluation and Mitigation Strategy
Posted in FDA Guidance, REMS, Tweets | No Comments »
Monday, 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. (more…)
Tags: appropriate use, approval, clinical trials, communication plan, Drug, ethnography, medication, medication guide, observational, ParagonRx, patient safety, REMS, REMS implementation, research
Posted in REMS | No Comments »
Wednesday, 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. (more…)
Tags: FDA draft guidance, ParagonRx, patient safety, REMS, REMS assessment, REMS elements, Risk Evaluation and Mitigation Strategy
Posted in Appropriate Use, REMS | No Comments »
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…)
Tags: Jeff Fetterman, ParagonRx, REMS, REMS effectiveness, REMS implementation, Risk Evaluation and Mitigation Strategy, risk management, risk mitigation
Posted in REMS, Tweets | No Comments »
Tuesday, March 30th, 2010
- Guest blog by Andrea J. Simon, PhD -
This blog by Andrea Simon, PhD, a corporate anthropologist, is one in a series that ParagonRx has initiated to help our readers better understand some of the trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance. We know you will find them of value and encourage you to comment on them.
In April, ParagonRx is hosting its Wednesday FoREMS webinar on the topic of organizing to effectively manage Risk Evaluation and Mitigation Strategies (REMS). And, in May, the Wednesday FoREMS will host a panel of industry leaders discussing how their organizations are building REMS capabilities and resourcing them in their product development and commercialization functions. In preparation for these upcoming webinars, I thought I would share with you some of my observations from the field and encourage you to share your own company’s perspectives on how you are reorganizing to create and effectively manage REMS. (more…)
Tags: appropriate use, communication plan, contingency plan, draft guidance, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, NDA, ParagonRx, regulatory, REMS, REMS approval, REMS development, REMS effectiveness, REMS implementation, REMS program, risk evaluation, Risk Evaluation and Mitigation Strategy, risk management, risk mitigation
Posted in General, REMS | No Comments »
Tuesday, March 23rd, 2010
Below is a qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.
The presence of any attribute increases the probability of a REMS requirement; some items may be more highly weighted than others: (more…)
Tags: clinical trials, Drug, drug interactions, FDA Guidance, mechanism of action, NDA, nda submission, ParagonRx, prolongation, regulatory, REMS, REMS development, REMS program, risk assessment, risk evaluation, sensitivity index, serious adverse event, stakeholder, submission, teratogenicity
Posted in REMS | No Comments »
