Navigation Links
New FDLI Book Maps Out Pharmacovigilance Provisions in More Than a Dozen Countries
Date:5/1/2009

Global Pharmacovigilance Guidebook First to Compile International Laws, Rules

WASHINGTON, May 1 /PRNewswire-USNewswire/ -- As recent events clearly indicate, the need to keep a close eye on pharmaceutical safety doesn't end with government approval to market the drug.

In March 2008, shipments of the blood thinner heparin made in China were discovered to be contaminated with excess sulfates often used to treat arthritis. The contaminated heparin caused dozens of deaths and hundreds of injuries.

In February 2009, the Food and Drug Administration accused Ranbaxy Pharmaceuticals, an Indian manufacturer of generic drugs, of falsifying data used to obtain regulatory approval for U.S. distribution.

These developments are just a few examples of why pharmacovigilance is now a global concern. Pharmacovigilance encompasses all phases of a product's lifecycle -- from data supporting regulatory approvals to enter a market to periodic inspections of foreign manufacturing facilities to postmarketing surveillance and adverse event reporting -- and beyond.

Many countries are working feverishly to develop their own set of pharmacovigilance laws and regulations, and it's increasingly difficult for manufacturers to keep current on new requirements.

With its new book, Global Pharmacovigilance Laws & Regulations: The Essential Reference, the Food and Drug Law Institute (FDLI) has made that job much easier. The comprehensive reference manual for pharmaceutical firms, medical device companies, life science attorneys, sales and marketing staff, compliance officers, regulatory affairs specialists and consultants lays out in user-friendly terms the pharmacovigilance laws and regulations for more than a dozen countries.

The 288-page book edited by Stephen L. Klincewicz, Global Head and Vice-President of Pharmacovigilance Sciences at the Benefit Risk Man
'/>"/>

SOURCE Food and Drug Law Institute
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Relsys International Launches the Pharmacovigilance Integrated Services Offering and Significantly Expands Project Delivery Capabilities
2. DIA Conference to Explore Global Pharmacovigilance and Risk Management Strategies and Regultory Frameworks
3. Kendle Appoints Ken Hintze, PhD, Vice President, Global Clinical Safety & Pharmacovigilance
4. HITSP to Address Provisions of American Recovery and Reinvestment Act
5. FEW Salutes House for Passing Legislation with Federal Worker Provisions; FERS Sick Leave Credit and FERS Redeposit Approved
6. Secova Reports Healthcare Provisions In The Stimulus Bill
7. Perot Systems Launches Webinar Series and Website Resources on Healthcare Stimulus Plan Provisions
8. China Healthcare Acquisition Corp. Announces Stockholder Approval of Charter Amendment to Permit Early Distribution of Its Trust Fund and to Permit Its Continued Existence Without Blank Check Company Provisions and Sets Payment Date
9. eHealth Initiative Lauds Inclusion of Health IT Provisions in American Recovery and Reinvestment Act
10. APHA Applauds Congress for Stimulus Bill Compromise; Health Provisions Are Step in Right Direction
11. AHIP Statement on Health Care Provisions in Economic Recovery Legislation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2015)... On Saturday, May 23, 2015, over 100 volunteers are ... City exactly five years to the day after the disastrous ... large fire tore through the Branches United Methodist Church and ... middle of the night as neighbors, staff and Branches' children ... though it is suspected that the fire began accidentally. Branches ...
(Date:5/23/2015)... NY (PRWEB) May 23, 2015 On ... that, “the company has been the target of ... a part of the company’s ongoing Information Technology (IT) ... health insurers.” , The most notable attack on ... when Anthem Inc., the nation’s second largest health insurer, ...
(Date:5/23/2015)... Javon Bea Mercy Health System CEO ... Rehabilitation Center, 557 N. Washington St., Janesville, will host ... 5:30-6:30 pm. , The 8-week clinic is lead by ... BSN, who will offer training that encompasses a warm-up, ... and show selection and weekly training plans. , The ...
(Date:5/22/2015)... (PRWEB) May 22, 2015 Pioneer Millworks, ... at the forefront of designing with reclaimed wood, introducing ... in Los Angeles, California. Their newest offerings, Vat 35, ... much-anticipated surface and color to America's largest design event. ... exhibit at each show, anxious to see and feel ...
(Date:5/22/2015)... 22, 2015 Hundreds of federal ... of individuals who allegedly experienced serious internal bleeding ... to move forward in the U.S. District Court, ... Order dated May 4, 2015, the Court has ... electronically stored information. Among other things, the Order ...
Breaking Medicine News(10 mins):Health News:Five Years After Fire, Branches Rebuilds Playground 2Health News:One Headline Making Cyber Attack Sparks Discovery of Another 2Health News:One Headline Making Cyber Attack Sparks Discovery of Another 3Health News:One Headline Making Cyber Attack Sparks Discovery of Another 4Health News:Pioneer Millworks to Reveal New Design Trends with Reclaimed Wood at Dwell on Design in LA 2Health News:Pioneer Millworks to Reveal New Design Trends with Reclaimed Wood at Dwell on Design in LA 3Health News:Court Overseeing Federal Xarelto Lawsuits Establishes Procedures Governing Preservation of Documents, Electronically Stored Information 2Health News:Court Overseeing Federal Xarelto Lawsuits Establishes Procedures Governing Preservation of Documents, Electronically Stored Information 3Health News:Court Overseeing Federal Xarelto Lawsuits Establishes Procedures Governing Preservation of Documents, Electronically Stored Information 4
... with murder, is not well and cannot attend court the ... three days ago following chest pain. ,"He is not ... to attend court proceedings for the next three days," said ... of Medical Sciences (AIIMS). ,According to Gupta, ...
... Michigan man is the third lucky man to have his ... doctors. // ,The medical team consisted of doctors ... and Kleinert, Kutz and Associates Hand Care Center who conducted ... am on Thursday. ,The recipient is David F. ...
... first thing that a health professional has to cope with ... woman and this can be well controlled by an old ... pain faced by the patient but is also cost effective ... Beth Israel Deaconess Medical Center, a study was done on ...
... used by scientists in mice that were bred with a ... potential tumors.// , ,This is thought to have ... the hormone, progesterone. This is indeed a teaser to researchers ... an option for women carrying the breast cancer gene. ...
... Bone and Mineral Research study by Indiana University-Purdue University Indianapolis ... later in life. The study is now available in an ... a print edition in 2007. ,'Our study ... fractures later in life, and the old exercise adage of ...
... Organization (ILO) report issued on Dec 1 (World AIDS Day), ... or fully due to// HIV and million jobs a year ... virus had a crippling effect on the workforce of many ... children has threatened the future working generations – the report ...
Cached Medicine News:Health News:RU-486, The Abortion Pill, May Quell The Breast Cancer Gene 2Health News:Exercise In Childhood Provides Lifelong Benefits 2Health News:ILO Reports On The Crippling Effects Of HIV On The Workforce 2
(Date:5/22/2015)... NEW YORK and KING OF PRUSSIA, ... Hemophilia Foundation (NHF) has awarded CSL Behring ... longstanding and unwavering commitment to advancing science and improving the ... by Paul Perreault , CEO and Managing Director, CSL ... New York City on May 21. ...
(Date:5/22/2015)... -- Research and Markets( http://www.researchandmarkets.com/research/28m7nx/guide_to_prepare ) has announced ... Application Dossiers for Oversea Medical device registration and ... to their offering. The Chinese medical ... the most growth potentiality, which is attracting more ... to penetrate such market. It is estimated that ...
(Date:5/22/2015)... 2015  In a sweeping analysis assessing the current ... Exchange researchers conclude that there remains considerable room ... all age groups, but especially for adolescents and young ... diabetes treatment, underscoring the need to address barriers to ... help type 1 patients achieve optimal metabolic control. ...
Breaking Medicine Technology:National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 2National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 3National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 4China Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation 2China Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation 3Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 2Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 3Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 4Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 5
... Medical Incorporated (OTCBB:ONCS), which is developing its ... treat solid tumor cancers, today announced that Dr. ... II Merkel cell carcinoma clinical trial, was featured ... Journal Newspaper.    (Logo: http://photos.prnewswire.com/prnh/20110314/MM64943LOGO ...
... Calif., March 6, 2012 AcelRx Pharmaceuticals, Inc. (Nasdaq: ... focused on the development and commercialization of innovative therapies ... dosing of the first patient in a Phase 3 ... novel sublingual patient-controlled analgesia system. This first ARX-01 Phase ...
Cached Medicine Technology:OncoSec's OMS ElectroImmunotherapy Technology Platform and its Ongoing Phase II Merkel Cell Carcinoma Clinical Trial Featured in Seattle Newspaper 2OncoSec's OMS ElectroImmunotherapy Technology Platform and its Ongoing Phase II Merkel Cell Carcinoma Clinical Trial Featured in Seattle Newspaper 3OncoSec's OMS ElectroImmunotherapy Technology Platform and its Ongoing Phase II Merkel Cell Carcinoma Clinical Trial Featured in Seattle Newspaper 4AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 2AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 3AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 4AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 5
... three software components that comprise the ... software components comprise the SmartPill GI ... SmartPill Data Receiver software and SmartPill ... integrated and indispensable parts of the ...
... RAPID 2 is the new second-generation ... Diagnostic System. , ,This software release ... enhancements for workflow efficiency and userfriendliness. Included ... as the Suspected Blood Indicator (SBI) which ...
... Analysis for POLYGRAM NET™ works with the ... analyze multichannel EGG signals. The EGG analysis ... by performing an automatic electrode impedance check ... beginning of a recording. If the electrode ...
... Bile Reflux Analysis for POLYGRAM NET® is an ... add-on allows medical professionals to upload and analyze ... reflux recorder. The primary difference is that bile ... a certain wavelength of light corresponding to the ...
Medicine Products: