Navigation Links
United BioSource Scientists, FDA, and Other Industry Leaders Present to Risk Management and Drug Safety Summit
Date:11/19/2008

Conference: How to Build Effective Global Programs Required by New Legislation

BETHESDA, Md., Nov. 19 /PRNewswire/ -- United BioSource Corporation's (UBC) Annette Stemhagen, DrPH, FISPE, and Gerald Faich, MD, MPH, FISPE, addressed the Risk Management and Drug Safety Summit held in Washington, DC, on October 28 and 29, along with Janet Woodcock, MD, Director, CDER, FDA; Jane Axelrad, Associate Director for Policy, CDER, FDA; Claudia Karwoski, acting director, Division of Risk Management Team, Office of Surveillance and Epidemiology, CDER; and other leading scientists from the pharmaceutical community.

(LOGO: http://www.newscom.com/cgi-bin/prnh/20070910/NEM007LOGO)

Co-sponsored by UBC and FDA News, the two-day conference was designed to help drug and biologics manufacturers understand how to build effective global risk management and drug safety programs, in response to the FDA Amendments Act of 2007 (FDAAA) and new international regulations now under development.

Patrick Lindsay, UBC's Executive Vice President, said "UBC was pleased to join forces with FDA News to bring together this esteemed group of experts in risk management. We recognize how important it is to master the critical components of the FDAAA to optimize pharmaceutical products, both for the safety of patients and to create value for pharma and biotech companies."

Dr. Stemhagen, Vice President, Epidemiology and Risk Management, UBC, spoke about "Using Registries and Large Streamlined Studies (LSS) to Improve Post-Approval Safety Surveillance, Risk Assessment and Risk Management," reviewing key factors to consider before implementing a registry or LSSs, best practices for using registries as part of risk management planning, and real-world case studies using LSSs.

Dr. Faich, Se
'/>"/>

SOURCE United BioSource Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Coalition for Pulmonary Fibrosis Launches Aggressive Ad Campaign Directed at United States Congress
2. United States continues to have highest level of health spending
3. United Medicorp, Inc.s Shareholders Approve All Proposals
4. Proven Terumo Coronary Guidewire Technology Is Now Available in the United States
5. Medical Services International Received Its First Order for Testing By Regulatory Agencies in the United States
6. Peoples United Financial CEO Has Surgery
7. Statement by Mike Leavitt Secretary of Health and Human Services on the United States-China Bilateral Meetings on Food and Drug Safety
8. More Than 100 Organizations Call for a National AIDS Strategy to End the Epidemic in the United States
9. Akers Biosciences, Inc. ABI or the Company Receipt of Further United States Military Contracts
10. Universal Health Care Coverage in the United States
11. Women Deliver Conference to Feature United Nations Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... ... July 30, 2015 , ... ... ‘Mary Jo Lawyer-Spano Mesothelioma Patient Registry Act of 2015’. The bill was ... Collins (R-NY), Peter King (R-NY), Betty McCollum (D-MN), Joe Kennedy (D-MA), and Leonard ...
(Date:7/30/2015)... ... , ... Western University of Health Sciences faculty, students and alumni were a ... sports and humanitarian event in the world this year and the single biggest event ... 25 through August 2, 2015, benefited from the participation of WesternU’s colleges of osteopathic ...
(Date:7/30/2015)... ... ... Between 2012 and 2014 HIV infection rates rose from five to seven percent ... untreated heroin use disorders share their needles and spread the infection. Florida does not ... Ultimately Florida’s HIV infection rates have bolstered to 23 percent due to lack of ...
(Date:7/30/2015)... ... 2015 , ... Gummy smile surgeon, Dr. Alex Farnoosh, now offers ... well as the patented gum depigmentation treatmet. Dr. Farnoosh is a renowned dentist with ... from around the world. , “Like treatment of any other disease or condition, making ...
(Date:7/30/2015)... NY (PRWEB) , ... July 30, 2015 , ... ... at Mount Sinai Earns National Cancer Institute Designation , The Tisch Cancer Institute ... a National Cancer Institute (NCI)-designated cancer center. TCI joins an elite group of ...
Breaking Medicine News(10 mins):Health News:Bill to Create Patient Registry for Deadly Cancer Introduced in Congress 2Health News:WesternU Makes Big Impact at Special Olympics 2Health News:WesternU Makes Big Impact at Special Olympics 3Health News:HIV Rates Rise in S. Florida, Harbor Village Comments on Health News Florida's Recent Article 2Health News:HIV Rates Rise in S. Florida, Harbor Village Comments on Health News Florida's Recent Article 3Health News:Gummy Smile Dentist, Alex Farnoosh DMD, is Now Offering Comprehensive Treatment Options for Gummy Smiles 2Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 2Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 3Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 4Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 5Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 6
... A class of drugs known as the triptans are known ... Since there are seven different triptan drugs available, it is ... at the University of Netherlands have carried out an ... over 18,000 patients. They find that in comparison with the ...
... to a new study, it shows that warfarin and aspirin ... patients at risk. Aspirin prevents blood clotting by stopping platelets ... blood clotting proteins. So both are known to help prevent ... date, it has been thought that warfarin is more effective ...
... the smallpox vaccine is being tested against cervical cancer. ... cervical cancer cases, but not everyone with the virus ... worldwide each year and causes 300,000 deaths. If it ... is a high survival rate. // ,Doctors ...
... sperm is the best indicator of a man's fertility, ... According to Dr. Dav Guzhik, chairman of obstetrics and ... infertility depends upon first establishing what's normal and abnormal. ... semen as normal if it contains 10 million sperm ...
... irregular or very long menstrual cycles have a higher ... needn't panic because the risk can be reduced markedly ... control. // ,Menstrual cycles 40 days or ... some sort of underlying metabolic abnormality. "Over an eight-year ...
... started menstruation could affect whether you suffer allergies.This is due ... development of the child. ,The study of Finnish ... ago. More than 4,740 pregnant women had been asked about ... their children in thirties were given allergy tests against types ...
Cached Medicine News:
(Date:7/30/2015)... PAUL, Minn. , July 30, 2015 ... medical devices using neuroblocking technology to treat obesity, metabolic ... will host a conference call on Thursday, August 6, ... results for the second quarter ended June 30, 2015, ... the Company,s vBloc® Neurometabolic Therapy, delivered via the Maestro® ...
(Date:7/30/2015)... July 30, 2015 ... reports analyzing tumor biomarker tests, imaging, endoscopy ... for the global industry by technology and ... Industry (Tumor Biomarker Tests, Imaging, Endoscopy and ... talking about 9 companies and supported with ...
(Date:7/29/2015)... Ill. , July 30, 2015  Astellas ... ACTIVE study evaluating the efficacy and safety of ... CRESEMBA® (isavuconazonium sulfate), under development for adults with ... Results from the study demonstrated that the trial ... in overall treatment response in isavuconazole-treated patients at ...
Breaking Medicine Technology:EnteroMedics to Host Second Quarter 2015 Financial Results and Company Update Conference Call 2EnteroMedics to Host Second Quarter 2015 Financial Results and Company Update Conference Call 3Cancer Diagnostics Market to see 12% CAGR to 2020: Analysis of Tumor Biomarker Tests, Imaging, Endoscopy, Biopsy and More in New Research Reports 2Cancer Diagnostics Market to see 12% CAGR to 2020: Analysis of Tumor Biomarker Tests, Imaging, Endoscopy, Biopsy and More in New Research Reports 3Cancer Diagnostics Market to see 12% CAGR to 2020: Analysis of Tumor Biomarker Tests, Imaging, Endoscopy, Biopsy and More in New Research Reports 4Cancer Diagnostics Market to see 12% CAGR to 2020: Analysis of Tumor Biomarker Tests, Imaging, Endoscopy, Biopsy and More in New Research Reports 5Cancer Diagnostics Market to see 12% CAGR to 2020: Analysis of Tumor Biomarker Tests, Imaging, Endoscopy, Biopsy and More in New Research Reports 6Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 2Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 3Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 4Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 5
... Inc. Magazine has ranked Precision Therapeutics ... growing privately owned companies in the U.S. with a ... This award recognizes the significant accomplishments of the fastest-growing ... established them among the best in their industries.  Precision ...
... 2011 /PRNewswire-Asia-FirstCall/ -- China Nepstar Chain Drugstore Ltd. ... drugstore chain in China based on the number of ... directors has authorized a share repurchase program. Under the ... up to US$20 million worth of its issued and ...
Cached Medicine Technology:Precision Therapeutics Named on Inc. 500|5000 2011 List and Recognized for Achievements in Personalized Medicine Industry 2Precision Therapeutics Named on Inc. 500|5000 2011 List and Recognized for Achievements in Personalized Medicine Industry 3China Nepstar Chain Drugstore Announces Share Repurchase Program 2China Nepstar Chain Drugstore Announces Share Repurchase Program 3
The care package includes a spare motor, fuse, Spare Fluorescent Bulb, additional Vibratome Feather Blades, Specimen Adhesive, Specimen Mounting Blocks, and a Specimen Tray....
... several (10 to 12) brain slices to ... while maintaining excellent viability. A mixture of ... saline. This initiates a circular flow and ... slices. Slices remain viable for hours while ...
... cooling water for the Vibratome 900R when it is ... in a location which has no source of tap ... thermoelectric heat pump. The reservoir tank holds seven ... 900R for up to eight hours. Water is ...
Punch set for Advanced Tissue Arrayer, 0.6 mm...
Medicine Products: