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 personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.

We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.

To learn more about PRA, please visit praintl.com, email endpoints@praintl.com or call our Global Headquarters.


'/>"/>
SOURCE PRA
Copyright©2012 PR Newswire.
All rights reserved

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:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):