Navigation Links
Almac's Clinical Technologies Division Undergoes Successful Joint GCP-GMP MHRA Inspection
Date:9/21/2010

hat expired products were not shipped to sites or dispensed to patients at clinical trial sites. Additionally the system was reviewed in general terms for its compliance with Good Clinical Practices (GCP). Almac Clinical Technologies received notice from MHRA that no serious findings were found in any of these areas or others investigated by the regulatory agency.

This was the first time in its history that Almac's Clinical Technologies division has been inspected by a regulatory authority. The inspection was conducted as part of a routine inspection plan and process of MHRA and was not triggered by any particular events, issues, or potential violations at Almac. MHRA routinely conducts inspections of both pharmaceutical companies and associated vendors who are involved in clinical trials. The results of the MHRA inspection were reported to Almac on 3 September 2010 after the company was inspected from 23-25 August 2010.

Jim Murphy, President of Almac's Clinical Technology division comments on this significant milestone: "The highly successful results of our first-ever regulatory inspection validate the efforts of all Almac employees to deliver the highest quality GCP and GMP systems and services to our clients. We take great pride in Almac's specialized full supply chain solution involving patient, site and drug management services, which are delivered using our IXRS technology. As patient safety is a key concern for Almac, we employ every effort to assure that patients in clinical trials are provided with products that are managed carefully to prevent expiration and meet all the requirements defined and monitored by regulatory agencies."

Bill Kane, Director of Quality Assurance for Almac's Clinical Technologies division, notes that Almac was not surprised by the results, given the company's long history of delivering quality systems and services to biopharmaceutical clients. "Almac has very stringent quality SOPs that clearly define and gui
'/>"/>

SOURCE Almac Group
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
8. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
9. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
10. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
11. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... , May 22, 2015 AcelRx Pharmaceuticals, ... focused on the development and commercialization of innovative therapies ... announced that interim chief executive officer Howie Rosen ... and chief financial officer Tim Morris will ... of the two presentations are as follows: ...
(Date:5/21/2015)... 2015 Research and Markets ... the "North American Active Wound Care Market ... Wound, & Ulcer), by End-User (In-Patient, & Out-Paient) ... to their offering. ,     (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ,The ... to grow at a CAGR of 3.1% from ...
(Date:5/21/2015)...  Cardica, Inc. (Nasdaq: CRDC ) today announced that ... the company,s vice president of operations, was granted an option ... a per share exercise price of $0.43, the closing trading ... pursuant to Cardica, Inc.,s Inducement Plan, which was approved by ... 5653(c)(4) of the Nasdaq Global Market for equity grants to ...
Breaking Medicine Technology:AcelRx Pharmaceuticals to Present at Two Upcoming Investor Conferences In June 2North American Active Wound Care Market 2015-2019 with Smith and Nephew, Molyncke HealthCare & ConvaTec Dominating 2Cardica Announces New Employment Inducement Grant 2
... Total quarterly revenues of $608 million increase 53 percent versus prior year; ... for prior year; Adjusted diluted EPS of $1.05 ... increases 2011 revenue guidance to a range of $2.72 to $2.80 billion; and ... a range of $4.55 to $4.65 and Reported or GAAP diluted EPS to ...
... Intercept Pharmaceuticals, Inc. (Intercept) and Les Laboratoires Servier ... worldwide ex-U.S. and Japan agreement for the discovery and ... type 2 diabetes and other metabolic indications. The collaboration ... proprietary bile acid analog chemistry and expertise targeting TGR5 ...
Cached Medicine Technology:Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 2Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 3Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 4Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 5Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 6Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 7Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 8Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 9Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 10Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 11Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 12Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 13Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 14Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 15Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 16Endo Pharmaceuticals Reports Second Quarter Revenues and Updates Financial Guidance, Reflecting the Acquisition of American Medical Systems 17Intercept Pharmaceuticals and Servier Announce Agreement for Intercept's TGR5 Research Program in Type 2 Diabetes 2Intercept Pharmaceuticals and Servier Announce Agreement for Intercept's TGR5 Research Program in Type 2 Diabetes 3
(Date:5/24/2015)... CA (PRWEB) May 24, 2015 ... clear indicator that the single best option for avoiding ... reveals that fitness level was the single most powerful ... for variables such as diabetes and family history of ... of maintaining lifelong heart and lung fitness. , The ...
(Date:5/23/2015)... On May 13, Nithyananda Yoga Foundation organized a ... learned through meditation and initiation at Special Holistic School ... Yogamaatha, a nine-year-old girl from North Carolina, stunned an ... the 2015 Business Advocacy Summit at Capitol Hill in ... In a demonstration that lasted three hours, Yogamaatha was ...
(Date:5/23/2015)... With the implementation of the Affordable Care ... difficult to provide their employees with a viable healthcare ... for employees stand to face strict penalties. Never before ... of a business’s success or failure. In an effort ... Doctors has created a varying level of less expensive ...
(Date:5/23/2015)... Parker, CO (PRWEB) May 23, 2015 On ... participated in MuckFest. The event was a 5k mud obstacle ... affects more than 2 million people worldwide, and the reason ... our community,” said Chad Davis, owner of Farrell’s eXtreme Bodyshaping. ... National Multiple Sclerosis Society.” , The event was not only ...
(Date:5/23/2015)... Chicago, IL (PRWEB) May 23, 2015 A ... of medical equipment from hospitals, surgery centers and other medical ... will be sold including endoscopy, lab, radiology, surgery, anesthesia, exam ... place Wednesday, May 27 and Thursday, May 28 starting at ... warehouse located at 1400 N. 25th Avenue, Melrose Park, IL ...
Breaking Medicine News(10 mins):Health News:Recent Mayo Clinic Studies Help to Highlight the Value of Cardio Testing 2Health News:Recent Mayo Clinic Studies Help to Highlight the Value of Cardio Testing 3Health News:Nine-Year-Old Reads Blindfolded at Business Advocacy Summit 2Health News:Nine-Year-Old Reads Blindfolded at Business Advocacy Summit 3Health News:Online USA Doctors Now Offers Cost-Saving Alternative Healthcare for Businesses 2Health News:Online USA Doctors Now Offers Cost-Saving Alternative Healthcare for Businesses 3Health News:Farrell’s eXtreme Bodyshaping Team Runs through the Muck for MS 2Health News:Over 5,200 Lots of Medical Equipment Will Be Sold by Live Auction 2
... , BRIDGEWATER, N.J., July 20 ... is possible to recruit large numbers of women, African Americans ... known as GRACE, is the largest study to date in ... differences in response to an HIV-1 therapy -- PREZISTA(R) (darunavir) ...
... , WHITE PLAINS, N.Y. and CAMBRIDGE, Mass., July ... FORMA Therapeutics today announced a partnership to accelerate LLS,s pipeline of ... , The collaboration will begin with a selection of ... to have the most promise of advancing into clinical trials in ...
... , , , ... average" scores in 11 out of 15 quality measures in the Puget ... more "above regional average" ratings than any of the other nine medical ... measures in the July report. Group Health received no "below regional average" ...
... , MINNEAPOLIS, July 20 ATS Medical, ... state-of-the-art cardiac surgery products and services, today announced the first ... Probe for the treatment of cardiac arrhythmias. The cryoablation ... Surgery at the Inova Heart & Vascular Institute in Falls ...
... CINCINNATI, July 20 The Southern Ohio Chapter of The ... and owner Rodger Roeser will partner with them to help ... well as fundraising events held year-round throughout the tri-state. , ... relies solely on the generosity of individuals, corporations and foundations ...
... ... for Social Change Present at the Greater Than Conference, July 26-28, 2009. The ... opportunities created by a growing awareness of sustainability for 21st Century leaders, featuring ... ...
Cached Medicine News:Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 2Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 3Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 4Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 5Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 6Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 7Health News:New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies 8Health News:The Leukemia & Lymphoma Society and FORMA Therapeutics Enter Collaboration to Bring New Therapies to Patients Faster 2Health News:The Leukemia & Lymphoma Society and FORMA Therapeutics Enter Collaboration to Bring New Therapies to Patients Faster 3Health News:Group Health Cooperative Scored Above Regional Average in 11 of 15 Quality Measures 2Health News:ATS Medical Announces First Use of the New ATS CryoMaze 10-S Probe 2Health News:ATS Medical Announces First Use of the New ATS CryoMaze 10-S Probe 3Health News:ATS Medical Announces First Use of the New ATS CryoMaze 10-S Probe 4Health News:Leukemia/Lymphoma Society Pleased to Announce Partnership in Southern Ohio with Eisen Marketing Group 2Health News:Interaction Associates and The Interaction Institute for Social Change Present at the Greater Than Conference 2Health News:Interaction Associates and The Interaction Institute for Social Change Present at the Greater Than Conference 3
... Products are constructed of a ... MEROCEL polyvinyl acetal sponge. Each ... beneficial to both surgeon and ... yet firm enough to gently ...
... Ophthalmic Products are constructed of ... lint-free MEROCEL polyvinyl acetal sponge. ... be beneficial to both surgeon ... and yet firm enough to ...
...
... Merocel Ophthalmic Products provide ... fiber free products for ... safe cleaning of fine ... Merocel material is highly ...
Medicine Products: