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 Management division of Johnson & Johnson; Yuung Yuung Yap, senior legal counsel at Johnson & Johnson Law Department (Europe); and Adrian Thomas, Worldwide Vice-President for Health Economics & Pricing and Chief Safety Officer for the Johnson & Johnson companies, will be an invaluable resource to manufacturers of pharmaceutical products and compliance specialists alike.

The book covers the pharmacovigilance programs of these countries and entities: Argentina, Australia, Brazil, Canada, China, Egypt, European Community, India, Japan, Mexico, Russian Federation, Singapore, Turkey and the United States.

For more information about the book, visit www.fdli.org.

Media: To obtain a review copy of Global Pharmacovigilance Laws & Regulations: The Essential Reference, contact Michael Levin-Epstein, Editor-in-Chief, FDLI, (202) 222-0897; mdl@fdli.org.

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field. For more information, visit www.fdli.org

    Contact: Michael Levin-Epstein, Editor-In-Chief
    The Food and Drug Law Institute
    202-222-0897
    mdl@fdli.org



'/>"/>
SOURCE Food and Drug Law Institute
Copyright©2009 PR Newswire.
All rights reserved

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:6/27/2017)... ... , ... Harbour , a DAO (decentralized autonomous organization) that harnesses the ... their technical specifications . , 2017 has seen an explosion of token launches ... which offerings will garner the greatest ROI. Dean Eigenmann, Co-founder and CEO of Harbour, ...
(Date:6/27/2017)... , ... June 27, 2017 , ... A January 18th ... projected to reach a staggering $6.81 billion by the year 2024 according to a ... a faster rate than those made from titanium. Los Angeles area clinic Beverly Hills ...
(Date:6/27/2017)... ... June 27, 2017 , ... Drs. Gregory Toback and ... in Mystic, CT. Covering the process and maintenance strategies of gum grafting and ... periodontal procedures. Drs. Toback and Urbanski practice as experienced periodontists in ...
(Date:6/27/2017)... Los Angeles, CA (PRWEB) , ... June 27, 2017 , ... ... on what crooked bites can indicate about early life experiences. What happens to a ... study reveals that stresses after birth can also take a toll on a baby’s ...
(Date:6/26/2017)... ... June 26, 2017 , ... The Centers for Advanced Orthopaedics ... of Richard Robinson as chief operating officer (COO). In this role, Robinson brings ... track record of simplifying business processes and developing growth strategies to increase market ...
Breaking Medicine News(10 mins):
(Date:6/9/2017)... , June 9, 2017 AirXpanders, Inc. (ASX: ... on the design, manufacture, sale and distribution of the ... the progress of its commercial roll-out in ... in more than one hundred (100) medical institutions and ... AeroForm offers a needle-free alternative for women who choose ...
(Date:6/7/2017)... , June 7, 2017 Endo International ... June 7, 2017, the Hon. Joseph R. Goodwin ... of West Virginia , entered a ... Inc. Pelvic Repair System Products Liability Litigation (the "MDL") ... MDL cases to provide expert disclosures on specific causation ...
(Date:6/3/2017)... 3, 2017  Eli Lilly and Company (NYSE: ... from the Phase 3 MONARCH 2 study showed ... inhibitor, in combination with fulvestrant, significantly improved progression-free ... in women with hormone-receptor-positive (HR+), human epidermal growth ... have relapsed or progressed after endocrine therapy (median ...
Breaking Medicine Technology: