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:9/12/2017)... and NEW YORK , Sept. 12, 2017 /PRNewswire/ ... ratings for global supply chains, has published the first annual edition of ... performance of more than 20,400 companies evaluated by EcoVadis, based on Scorecard ... and 2016. ... Global CSR Risk & Performance Index ...
(Date:9/12/2017)... , Sept. 12, 2017  ValGenesis Inc., the ... (VLMS), is pleased to announce the appointment of ... of its Board of Directors and Chairman of ... enables life science companies to manage their entire ... of paper in this process. Furthermore, ValGenesis VLMS ...
(Date:9/9/2017)... Sept. 8, 2017 Dealmed Medical Supplies, ... of medical equipment, supplies, drugs, vaccines, and specialty medical ... into an agreement to acquire Vantage Medical Supplies, a ... Holtsville, New York . ... new and emerging medical practices, will operate under the ...
Breaking Medicine Technology:
(Date:10/12/2017)... WAUSAU, Wis. (PRWEB) , ... October 12, 2017 ... ... formulated standard products to meet the demand of today’s consumer and regulatory authorities ... team of probiotic experts and tested to meet the highest standard. , ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized health ... expanded their existing home health joint venture through an agreement, effective October 1, ... joint venture home health company with Asante, delivering clinically integrated care, for the ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... HMP ... the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare ... City on October 11, 2017. , The annual award competition recognizes editorial and design ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and Grand ... Best and Brightest in Wellness® by Best and Brightest. OnSite Wellness will be ... Oct. 20 from 7:30 a.m. to 2 p.m. at the Henry Autograph Collection ...
(Date:10/12/2017)... FL (PRWEB) , ... October 12, 2017 , ... ... presenting the latest in wound care advancements to physician colleagues, skilled nursing facility ... is titled, "Navigating the Treacherous Waters of Wound Care." , "At many of ...
Breaking Medicine News(10 mins):