Navigation Links
ParagonRx Creates New Website Featuring REMS Help Center for Pharma
Date:7/13/2009

WILMINGTON, Del., July 13 /PRNewswire/ -- ParagonRx, a Delaware-based company which specializes in programs for the appropriate use of medications, has launched a new website - www.paragonrx.com - that includes a "REMS Hub" for pharmaceutical and biotech companies needing information and assistance in complying with new FDA requirements to ensure the medical benefits of a drug outweigh its risks and dangerous side effects.

"REMS, or Risk Evaluation and Mitigation Strategy, requires a whole new mindset for many professionals in the industry," according to ParagonRx CEO Jeffrey Fetterman, "in that patient safety is no longer merely a statistic that is passively measured for regulatory compliance. Now, patient safety is an objective that is actively managed by many functional groups and disciplines, including pharmacovigilance, marketing, medical, regulatory and legal. In many ways, risk management, including REMS, is becoming its own new discipline, and we believe that our online REMS Hub will be of great use to our colleagues in many disciplines.

"Our job is always to make our clients jobs easier," Fetterman continues. "The new website was specifically designed to make it simpler to share the new lessons being learned as we work through the evolving REMS processes. We all share an overwhelming desire to improve patient safety while ensuring the benefits of a pharmaceutical or biological solution can address a patient's health needs. Our goal is to use the website and Internet world to help build better communication and educational strategies reducing risks for physicians and patients."

The REMS Hub addresses the related but varying needs of pharma and bio companies working with risk management and REMS in any of a product's key stages - development, peri-approval, launch, and post-marketing. The Center also explains how a
'/>"/>

SOURCE ParagonRx
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related biology technology :

1. Digital Unions RT1(TM) Software Creates Telegenetics Network for Region 3 Genetics Collaborative
2. Change in Medicare and Medicaid Legislation Creates Market for Antimicrobial Coatings In the U.S.
3. MIT creates gecko-inspired bandage
4. ADVENTRX Creates Executive Vice President Position and Announces New Chief Financial Officer
5. CryoPort Creates Personal Wall on Wallst.nets Financial Social Community, my.wallst.net
6. Inclinix Expansion Creates New Position and Promotions
7. Monsantos Industry-Leading Seed Position Creates Accelerated Biotech Trait Opportunity in Latin America
8. New process creates 3-D nanostructures with magnetic materials
9. MRI Expands Energy Role: Launches Center for Integrated Algal Research and Creates Director of Energy Programs Position
10. Pathway for Biosimilars Act Protects Patients, Promotes Competition, Preserves Innovation and Creates Quality Jobs, Lilly Says
11. GSK and Pfizer Innovative Agreement Creates Specialist HIV Company
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2013)... Dennis R. HIll M.D. Radiation Oncologist at the ... recently there has been a promotion of the idea that ... seed, or low dose rate, brachytherapy for prostate cancer. The ... a shorter half life, and gives a higher biologically effective ... has a higher average energy than the other commonly used ...
(Date:5/24/2013)... 24, 2013 Senomyx , Inc. (NASDAQ: ... science technologies to discover, develop, and commercialize novel flavor ... , Ph.D., the Company,s Vice President, Biology and ... & Corporate Communications, will present an overview of Senomyx,s ... a.m. Eastern Time (7:25 a.m. Pacific Time) during the ...
(Date:5/24/2013)... Madison, WI (PRWEB) May 24, 2013 ... to the discovery and development of calcium-binding proteins ... publication of safety assessment study of apoaequorin ... an international journal published for the British Industrial ... the study was to investigate potential adverse effects, ...
(Date:5/23/2013)... Can economic incentives such as gift ... of the public to increase their donations of blood? ... Carey Business School Assistant Professor Mario Macis says ... large body of recent research that supports their argument, ... issue of Science that the World Health Organization and ...
Breaking Biology Technology:Dennis R. Hill MD HDR Prostate Brachytherapy Specialist Compares Prostate Cancer Treatment Options: Not All Low Dose Rate Brachytherapy Isotopes Are the Same 2Dennis R. Hill MD HDR Prostate Brachytherapy Specialist Compares Prostate Cancer Treatment Options: Not All Low Dose Rate Brachytherapy Isotopes Are the Same 3SENOMYX TO WEBCAST CORPORATE PRESENTATION AT THE CITI 2013 GLOBAL CONSUMER CONFERENCE 2Safety Assessment Study of Apoaequorin Published in Food and Chemical Toxicology 2Offering Economic Incentives to Attract Blood Donations Should Be Encouraged, Research Team writes in Science 2Offering Economic Incentives to Attract Blood Donations Should Be Encouraged, Research Team writes in Science 3
... Feb. 9 Celsis In Vitro Technologies (Celsis,IVT), ... life science,products and laboratory services company, and Wisconsin-based ... of ADME-Tox testing in primary,hepatocytes. Celsis IVT ... use with Promega,s bioluminescent ADME-Tox assays, including,the P450-Glo(TM) ...
... of Pharmaceuticals in a New U.S. Political AdministrationPHILADELPHIA, ... start of the first annual conference on Managed ... at the Loews Philadelphia Hotel. The conference ... needed to prepare for future changes in health ...
... Measuring Prevalence of Sleep Apnea Among Insomnia PatientsALBUQUERQUE, N.M., ... (SHHI) was awarded a grant to study one of ... connects insomnia to psychological factors -- stress, racing thoughts, ... pills or talk therapy. Pitted against the CW ...
Cached Biology Technology:Celsis In Vitro Technologies and Promega to Offer Fast, Reliable Solutions for ADME-Tox Testing With Primary Hepatocytes 2Celsis In Vitro Technologies and Promega to Offer Fast, Reliable Solutions for ADME-Tox Testing With Primary Hepatocytes 3ExL Pharma Presents The Pharmaceutical Managed Markets Insight & Marketing for the Pharmaceutical Industry Conference 2ExL Pharma Presents The Pharmaceutical Managed Markets Insight & Marketing for the Pharmaceutical Industry Conference 3Controversial Study to Test Link Between Insomnia and Sleep Apnea 2
(Date:5/23/2013)... Pacific Northwest National Laboratory honored more than 165 ... intellectual property at PNNL,s annual Intellectual Property Commercialization ... Department of Energy national laboratory named materials scientist ... work developing battery materials that can store large ... grid, and reduce the time it takes to ...
(Date:5/23/2013)... The tight wrapping of genomic DNA around nucleosomes ... gene expression. A team of Ludwig-Maximilians-Universitaet (LMU) in ... DNA to be locally displaced from nucleosomes for ... is stored in the cell nucleus, wrapped around ... pairs of four different histone proteins and accommodating ...
(Date:5/23/2013)... have succeeded in treating cerebral palsy with autologous cord ... a 2.5 year old boy had been in a ... Just two months after treatment with the cord blood ... following months, the child learned to speak simple sentences ... a Korean study, dispel the long-held doubts about the ...
Breaking Biology News(10 mins):PNNL staff recognized for scientific accomplishments, moving technologies into the marketplace 2Biochemistry: Unspooling DNA from nucleosomal disks 2First successful treatment of pediatric cerebral palsy with autologous cord blood 2
... inventions are birthed at a bar, their futures scribbled ... technological change in X-rays in more than a century, ... It was 2000. Otto Zhou was the principal investigator ... Naval Research to find applications for carbon nanotubes. Zhou ...
... atmospheric mercury emissions should quickly reduce mercury levels in ... week in the Proceedings of the National Academy of ... loading at rates relevant to atmospheric deposition resulted in ... fish in only three years. This is ...
... and ... terminal solutions, WALL, N.J., Sept. 18 ... in finger-based biometric,identification and wireless public safety solutions, ... technology to the hospitality and,retail industries, announced today ...
Cached Biology News:UNC nanotech spin-off forms new venture with Siemens 2UNC nanotech spin-off forms new venture with Siemens 3New study shows fish respond quickly to changes in mercury deposition 2New study shows fish respond quickly to changes in mercury deposition 3Radiant Systems Selects BIO-key(R) Biometric Software for POS Solution 2Radiant Systems Selects BIO-key(R) Biometric Software for POS Solution 3
...
BD Primaria 35 mm Cell Culture Dish with Easy-Grip design, surface-modified polystyrene for enhanced cell culture. (20/sp, 200/ca) Packaging: 20 / sleeve, 500 / case ...
...
BD Falcon insert HTS 96 well, square A-bottom with lid. PET membrane, sterile. (5/ca) Packaging: 5 / pack, 5 / case ...
Biology Products: