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:6/24/2016)... 24, 2016  Collagen Matrix, Inc., ("Collagen Matrix") ... manufacturing of collagen and mineral based medical devices ... Bill Messer has joined the company ... leverage the growing portfolio of oral surgery, neurosurgery, ... Bill joins the Collagen Matrix executive team as ...
(Date:6/24/2016)... Research and Markets has ... 2015-2025: Applications, Technologies, Forecasts" report to their ... Electronics, Smart Skin, Structural Health Monitoring, Composite Smart ... electronics involves electronic and/or electrical components and circuits ... structures such as vehicle bodies or conformally placed ...
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
Breaking Medicine Technology:
(Date:6/26/2016)... Aliso Viejo, California (PRWEB) , ... June 26, 2016 , ... ... for Final Cut Pro X. , "Film editors can give their videos a whole ... artistically," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
Breaking Medicine News(10 mins):