HOME >> MEDICINE >> NEWS
American Association of Pharmaceutical Scientists tapped to manage PQRI

ALEXANDRIA, Va., Nov. 16 -- In effort to reduce the regulatory burden on the Food and Drug Administration (FDA) and the pharmaceutical industry, the American Association of Pharmaceutical Scientists (AAPS) announced today the formation of the Product Quality Research Institute (PQRI). The goal of this collaborative effort between the government, industry and academia is to produce science-based policy that ensures quality reviews without unnecessary testing. The Institute's recommendations are expected to speed new drug approvals and reduce the industry's cost for pharmaceutical development. Ultimately, the public will benefit because of lower costs and faster availability of new drugs for life-threatening diseases.

"We are not testing actual drugs," said Larry Augsburger, AAPS President. "We are testing processes and procedures that will be used to help verify pharmaceutical properties and their effectiveness. Recommendations will help fast-track pharmaceuticals, benefiting all Americans, especially those who currently have no disease treatment options available."

How PQRI Works

Under the purview of AAPS, PQRI will consist of a board of directors, a steering committee and technical committees. The five-member board of directors is charged with the administrative management and operations of the Institute. The board has authority over the collection and disbursement of funds and the administrative procedures required to guarantee effective operations.

Following the lead of the technical committee, working groups of scientists will perform research projects aimed at streamlining policy, while still ensuring the highest level of product quality. The technical committee then reviews the findings for scientific validity. Assuming approval, the steering committee votes on whether or not to make a recommendation to the FDA. The FDA can either accept or reject the findings.

"PQRI represents a unique collaboration between F
'"/>

Contact: Marie Bertot
305-573-9955
American Association of Pharmaceutical Scientists
15-Nov-1999


Page: 1 2

Related medicine news :

1. Consumers with disabilities empowered by American Disabilities Act
2. Definition of persistent vegetative state available from American Academy of Neurology
3. African-American women with endometrial cancer have more aggressive cancer than Caucasian women
4. New colorectal cancer screening recommendations for African Americans
5. American Thoracic Society Journal news tips for March 2005 (second issue)
6. Community care tops medical care at preventing heart disease in black Americans
7. Researchers say breast cancer in Africa may provide clues to the disease in African-Americans
8. Obesity among African-American stroke survivors increases risk factors for recurrent stroke
9. Awards & fellowships at the International & American Association for Dental Research General Session
10. American Academy of Neurology presents 57th Annual Meeting in Miami Beach
11. News tips from the 2005, 54th Annual Scientific Sessions of the American College of Cardiology

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2016)... ... , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... a whole new perspective by using the title layers in ProSlice Levels to ... ProSlice Levels contains over 30 Different presets to choose from. FCPX users ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... have been diagnosed with endometriosis. These women need a treatment plan to not ... comprehensive approach that can help for preservation of fertility and ultimately achieving a ...
(Date:6/25/2016)... , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on ... Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ability ... fumigation is not a common occurrence, but a necessary one in the event that lice ...
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/25/2016)... ... , ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter ... bar too high can result in disappointment, perhaps even self-loathing. However, those who set ... , Research from PsychTests.com reveals that behind the tendency to set low ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology ... outcomes platform, Bracket eCOA (SM) 6.0, at the 52 ... 30, 2016 in Philadelphia , Pennsylvania.  A ... product of its kind to fully integrate with RTSM, will ... 6.0 is a flexible platform for electronic clinical outcomes assessments ...
Breaking Medicine Technology:
Cached News: