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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



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SOURCE Food and Drug Law Institute
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