Navigation Links
PRA Late Phase Expert to Present at Conference
Date:9/20/2012

RALEIGH, N.C., Sept. 20, 2012 /PRNewswire/ -- PRA, a leading Clinical Research Organization, announces that one of our Late Phase experts will speak at the 15th annual CBI Registries and Post-Approval Studies Congress being held in Chicago from 19-21 September.

On 21 September at 9:15AM CDT, Dat Nguyen, Scientific Affairs Director of PRA's Late Phase Services group, will deliver a presentation titled, "The Reality of REMS – Implementation and Impact." His speech will address the FDA's guidance for REMS programs stemming from the implementation of the 2007 amendment to the Food, Drug, and Cosmetic Act. Specifically, Dr. Nguyen will present a case study that reviews current trends and operational considerations for REMS programs, including execution challenges and proactive solutions to meet regulatory requirements.

An experienced research scientist, Dr. Nguyen possesses extensive knowledge of the global drug development process with an emphasis on post-marketing and minimal risk studies. His background includes a number of positions in the pharmaceutical industry and activities spanning from initial study design to authoring major publications. In his current role at PRA, Dr. Nguyen utilizes his expertise to provide strategic and innovative post-marketing and minimal risk design, as well as operational support to ensure proper study execution.

PRA's Late Phase Services group supports global and regional post-approval studies with management locations centralized in PRA's Horsham, Pennsylvania; Mannheim, Germany; and Singapore offices. This highly experienced team assists clients with the post-marketing process by planning and conducting safety-surveillance studies, large simple trials, registries, restricted access programs, risk management programs, and diagnostic and biomarker research. 

About PRA
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personali
'/>"/>

SOURCE PRA
Copyright©2012 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related medicine technology :

1. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
2. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
3. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
4. Retrospective Study Suggests that Stereotactic Ablative Radiotherapy (SABR) Can be a Viable Option for Treating Early-Stage Lung Cancer in Operable as well as Inoperable Patients; Phase III Randomized Trial Now Under Way
5. Ultragenyx Announces Phase 1 Results of UX001 in Hereditary Inclusion Body Myopathy (HIBM), a Rare Neuromuscular Disease
6. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
7. Isis Initiates Phase 2 Study of ISIS-APOCIIIRx in Patients with Hypertriglyceridemia
8. Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403
9. Results Reported for Phase Ib Open-Label Clinical Trial for the Treatment of Depression Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
10. Pearl Therapeutics Phase 2b Twice-Daily Dosing Data Suggest Morning and Evening Benefit of PT003 in Patients with COPD
11. Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2013)... 19, 2013   NextDocs announced today that ... research organization, at DIA 2013 , the Drug ... present case studies that explore best practices for making ... trial master file (eTMF) systems. Sharon ... alongside Krystyna Kowalczyk , executive vice president of ...
(Date:6/19/2013)... , June 19, 2013  Caradigm today ... a solution designed to help healthcare organizations ... data while supporting their compliance with data ... represents a milestone in the delivery of ... capabilities for health systems. ...
(Date:6/19/2013)... , June 19, 2013   Voices Against ... finding a cure for brain cancer, today announced that ... grant to support the clinical investigation of Toca 511 ... high grade glioma brain cancer (Grade 3 or Grade ... novel treatments for advanced cancer, with an initial focus ...
Breaking Medicine Technology:NextDocs and Novella to Present on eTMF at DIA 2013 2Caradigm Provisioning Helps Healthcare Organizations Improve Clinical Efficiency, Manage Risk 2Caradigm Provisioning Helps Healthcare Organizations Improve Clinical Efficiency, Manage Risk 3Voices Against Brain Cancer Awards Grant to Tocagen to Support Investigation of Toca 511 & Toca FC in Patients with Recurrent Brain Cancer 2Voices Against Brain Cancer Awards Grant to Tocagen to Support Investigation of Toca 511 & Toca FC in Patients with Recurrent Brain Cancer 3
... MINNETONKA, Minn., Aug. 25 MedNet Solutions, a ... clinical study management systems, is pleased to announce ... Inc. 5000 list for the fourth year in ... compiled annually by Inc. magazine, recognizes ...
... VIEJO, Calif., Aug. 25 Ambry Genetics, a global ... acquired the Illumina HiSeq 2000 Next Generation Sequencing System ... BeadXpress Genotyping System. Ambry Genetics has been an early ... extensive experience as a Certified Service Provider. A team ...
Cached Medicine Technology:MedNet Solutions Named to the Inc. 5000 List of Fastest Growing Companies for the Fourth Consecutive Year 2Ambry Genetics Announces the Addition of Illumina HiSeq 2000 and First 510(K) Approved BeadXpress® to Its Sequencing and Genotyping Capabilities 2
(Date:6/19/2013)... Texas (PRWEB) June 19, 2013 ... today announced its intent to purchase privately ... Florida, a leader in wheelchair accessible vehicle sales, ... of Auto Mobility Sales, Inc compliments and expands ... wheelchair accessible mobility dealers . The acquisition ...
(Date:6/19/2013)... CA (PRWEB) June 19, 2013 Kleritec, ... its website located at http://www.kleritec.com . In the ... creative, pre-selected, art and activities packages for pre-school and ... products as a method to aid teachers across the ... and engaged in learning. , Included in the art ...
(Date:6/19/2013)... Citi Bike has come to New York City in ... to know for sure how many patients will choose to take ... the option. In fact, he’s happy about anything that might ... it more convenient for them to visit his office at 133 ... Alternative Medicine at Back and Body Medical and an experienced ...
(Date:6/19/2013)... - In a major international study led by researchers ... the targeted therapy ibrutinib continues to show remarkable promise ... lymphoma (MCL). , The most recent interim findings of ... the New England Journal of Medicine . Previous ... 54th American Society of Hematology Annual Meeting and Exposition. ...
(Date:6/19/2013)... Children had half as many emergency department visits ... on five or more days a week, according to ... Children,s Hospital and Johns Hopkins University. , The new ... Journal of Pediatrics and will be presented at ... an important step in understanding where primary care practices ...
Breaking Medicine News(10 mins):Health News:HASCO Medical, Inc. to Acquire Auto Mobility Sales, Inc. 2Health News:Kleritec Announces Addition of Educational Products. 2Health News:New York City's Back and Body Medical Welcomes Citi Bike to Midtown Manhattan 2Health News:New York City's Back and Body Medical Welcomes Citi Bike to Midtown Manhattan 3Health News:Ibrutinib continues strong showing against mantle cell lymphoma 2Health News:Extended primary care office hours might help keep kids out of the emergency department 2
... in heart attack or mortality rates , , SUNDAY, Nov. 4 ... to date, Harvard researchers report that they have found drug-eluting ... than bare metal stents do. , "There has been a ... investigator Dr. Laura Mauri, an assistant professor of medicine at ...
... ... Heart Association,s Scientific Sessions 2007 ... 4 , WHO: Dr. Amir Lerman, Professor of Medicine, Mayo Clinic, Rochester, MN ... Sweden Mr. Israel Schreiber, President ...
... North Carolina team of doctors, nurses, hospitals and emergency ... to provide faster, more effective treatment for heart attack ... fancy new equipment. But it does require competitors to ... move treatment forward empowering emergency services personnel in ...
... props open closed aortas in older patients, research suggests ... high-risk heart patients with narrowed aortas who typically need ... option -- an implanted, balloon-expandable aortic valve. , The ... the problem valve and then inflated, experts said. In ...
... increase in their risk of heart attacks or other ... the largest-ever study of the issue, being presented at ... Scientific Exposition in San Francisco. , Although donors are ... (hypertension) during follow-up, it is unclear whether this represents ...
... Union Election, Note Hospital System Failing ... to Live Up to its Own ... elected officials and other healthcare activists joined hospital,workers from the St. ... Hospital on Saturday, where they called for the health,system,s leadership to ...
Cached Medicine News:Health News:Drug-Coated Stents No Riskier in Long Run Than Bare Metal Ones 2Health News:Drug-Coated Stents No Riskier in Long Run Than Bare Metal Ones 3Health News:How Early Can We Detect Cardiovascular Disease Less Expensively ... Even in Childhood? 2Health News:RACE: a statewide model of better, faster heart attack care 2Health News:RACE: a statewide model of better, faster heart attack care 3Health News:Balloon Valve May Be Alternative to Open-Heart Surgery 2Health News:Balloon Valve May Be Alternative to Open-Heart Surgery 3Health News:No increase in cardiovascular risk for living kidney donors 2Health News:Healthcare Workers, Community Activists Call for Fair Election Agreement at St. Joseph Health System 2
The Fujinon's R410 laparoscope is the first to bring a 410,000 pixel CCD to the end of the scope. Superior imaging and color replication, along with a unique lens washing capability make the R410 the...
The ACMI™ Operative Laparoscopy System is designed for single- and dual-incision CO2 laser procedures and is used with 45cm laparoscopic instruments....
The edge-to-edge clarity of the laparoscopes provides excellent image definition.Even small structures are easily recognized due to the optimal depth of focus. The outstanding optical quality provide...
Stryker bariatric laparoscopes set the standard in picture quality....
Medicine Products: