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Latest Pharmacovigilance Stories

2014-09-18 04:21:12

LEIDEN, The Netherlands, September 18, 2014 /PRNewswire/ -- A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the current regulatory system for medicines in Europe can be used in a more efficient and effective manner. Andre Broekmans, chairman of Escher: " Overall, the EU regulatory system operates well, however important recent changes had not yet been evaluated. One of our conclusions is that pathways that were intended to...

2014-08-26 23:03:13

ClinCapture by Clinovo becomes the first Open Source Electronic Data Capture (EDC) System to receive the WHO Drug Dictionaries Medical Coding Certification by Uppsala Monitoring Center (UMC). Sunnyvale, CA (PRWEB) August 26, 2014 Clinovo, the leading technology-focused Contract Research Organization (CRO) headquartered in Sunnyvale (CA), has officially received the WHO Drug Dictionaries Medical Coding certification. With this milestone, ClinCapture becomes the first open source EDC system...

2014-08-14 08:30:05

First Patient Dosed in the EU Post-Authorization Safety Study MOUNTAIN VIEW, Calif., Aug. 14, 2014 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today provided an update on its European Medicines Agency (EMA) post-approval studies for ADASUVE(®) inhalation powder, pre-dispensed (loxapine). As part of the ADASUVE approval process with the EMA, Alexza is required to conduct five post-approval studies: -- a benzodiazepine interaction study - study completed and data...

2014-07-11 23:01:56

A recent regulatory filing exposes that the number of adverse events in 2013 reported by patients taking Acthar was almost 14% of prescriptions. Zoll, Kranz & Borgess is investigating this potentially dangerous drug. Toledo, Ohio (PRWEB) July 11, 2014 As reported by the New York Times (Morgenson 7/10/14) and FiercePharma (Weintraub 7/11/14), a significant number of severe adverse events such as renal failure, increases in blood sugar, abdominal issues and even death from the...

2014-07-08 23:07:49

ResearchMoz include new market research report "Global Blood Plasma Market Report: 2014 Edition" to its huge collection of research reports. View Full Report at http://www.researchmoz.us/global-blood-plasma-market-report-2014-edition-report.html. Alabny, NY (PRWEB) July 08, 2014 Plasma is a composite mixture of more than 700 proteins and other substances which are vital for the smooth functioning of the human body. Plasma is the liquid component of blood, constituting around 50%...

2014-07-01 08:30:55

DUBLIN, July 1, 2014 /PRNewswire/ -- Research and Markets (http://www.researchandmarkets.com/research/7xtphb/pharmacovigilance) has announced the addition of the "Global Pharmacovigilance (Pre-Clinical Studies, Phase I, Phase II, Phase III, Phase IV or Post-Marketing Surveillance) Market - Forecast to 2019" report to their offering. http://photos.prnewswire.com/prnh/20130307/600769 A rising tide of regulatory expectations, tougher inspection regime and instant need of patient reporting has...

2014-06-30 23:22:00

Theresa L. Markey is recognized as a National Association of Professional Women VIP Woman of the Year for her outstanding leadership and commitment within her profession Garden City, NY (PRWEB) June 30, 2014 The National Association of Professional Women honors Theresa L. Markey as a 2014 Professional Woman of the Year. Ms. Markey is recognized with this prestigious distinction for leadership in business. As the largest, most-recognized organization of women in the country, spanning...

2014-06-25 23:03:18

OMICS Group is delighted to announce the 3rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials on October 27-29, 2014 at Hyderabad India, with the theme "Safer Drugs to Market by Analyzing the Latest Developments in Pharmacovigilance, Drug Safety and Risk Management." Los Angeles, CA (PRWEB) June 25, 2014 Pharmacovigilance -2014 is intended to gather the renowned people under the same platform to share their advanced research about pharmacy,...

2014-06-23 23:12:15

Drugmakers for the first time must now report adverse drug reactions (ADRs) caused by their products in all uses, including off-label use. In a July 1, 2014 webinar, FDAnews and EU law expert Elisabethann Wright, a partner in Hogan Lovells’ Brussels, Belgium office, will provide answers and in-depth information. Falls Church, VA (PRWEB) June 23, 2014 Complying With the New EMA Pharmacovigilance Rules Filling the Obligations Without Committing Off-Label Violations **FDAnews Webinar**...

2014-06-03 23:00:56

Chris Geiger, author of “The Cancer Survivors Club”, and Dr. Fergus Sweeney, Head Inspections and Human Medicines Pharmacovigilance Division at the European Medicines Agency, will keynote the PhUSE Annual Conference in London, UK in October 2014. (PRWEB) June 04, 2014 PhUSE is proud to announce Chris Geiger and Dr. Fergus Sweeney as keynote speakers for their 10th annual conference which is themed “Data Transparency”. Following keynotes from Dr. Ben Goldacre in 2013, Charles...


Word of the Day
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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