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Drugs: General
Requirements Webinar
Food and Drug Law and Regulation Distance Learning Series

     
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December 16, 2009
12:00-1:30 p.m. ET | Webinar

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  • General Information
  • Speaker Bios
  • Webinar Requirements

Faculty Members
Daniel A. Kracov
, Partner, Chair, FDA and Healthcare Practice, Arnold & Porter LLP
William W. Vodra, Senior Counsel, Arnold & Porter LLP
Jennifer Newberger, Associate, Arnold & Porter LLP

FDLI’s distance-learning lecture series will cover the chapters of the best-selling treatise, Food and Drug Law and Regulation. The Dec. 16 presentation is on “Drugs: General Requirements: Jurisdiction, Definitions, Adulteration and Misbranding, Imports and Exports”. This series is developed for attorneys, consultants and academics who want to learn about food and drug law in general or clarify understanding of a particular area.

Registration Fees
$199 Member
$299 Non-member
$199 Academics & Government

Special CD Price!
Purchase the CD set for just $75 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, DC and Maryland addresses will be
charged 6% sales tax.

Please contact Customer Service at (800) 956-6293 or (202) 371-1420,
or by e-mail at CSDept@fdli.org, if you have any questions about your conference registration or CD order.

DANIEL A. KRACOV is a Partner in the law firm of Arnold & Porter LLP in Washington, DC where he heads the Food and Drug Administration (FDA) and Healthcare Practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics and medical devices. Mr. Kracov regularly handles product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized expertise in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies. Mr. Kracov received his undergraduate degree, magna cum laude, from the University of Maryland and his JD from the University of Virginia.

WILLIAM W. VODRA is a Senior Partner in the Washington, DC law firm of Arnold & Porter. Since joining that firm, Mr. Vodra has practiced extensively in all aspects of FDA regulation. He has also headed defense teams in major product liability cases and has participated in advertising disputes between competitors. Mr. Vodra's previous positions include Associate Chief Counsel for Drugs, Food and Drug Administration; Assistant Chief Counsel, Drug Enforcement Administration; and Special Assistant DC U.S. Attorney. He currently serves on the editorial boards of Regulatory Affairs and Clinical Research and Regulatory Affairs, is a former Editorial Advisory Board member of the Food and Drug Law Journal, and has published in these journals and in the Drug Information Journal. Mr. Vodra received his BA in economics at the College of Wooster in Ohio and his JD from Columbia University School of Law.

JENNIFER NEWBERGER is an Associate in the Washington, DC office of Arnold & Porter LLP. Her practice focuses on regulatory and public policy issues that arise for clients in the pharmaceutical and medical device sectors. Ms. Newberger's work includes assisting clients in matters related to the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), counseling them regarding regulatory compliance, legislative issues, and litigation and reimbursement strategies. Prior to law school, Ms. Newberger worked as a Public Health Analyst at the Centers for Disease Control and Prevention (CDC) in Atlanta, where she focused primarily on designing workplace HIV/AIDS prevention programs for companies in southern Africa. Ms. Newberger holds her BA from Washington University in St. Louis, her MPH from Emory University and her JD from the University of Miami School of Law.

Webinar Equipment Requirements
Minimum requirements to run Conference America’s WebEcho, the service that delivers visual presentations over the web in combination with a standard conference:
Windows 98 / ME / NT / 2000 / XP

Other compatible Operating Systems:
• SPARC Solaris
• Netscape 4.7
• IRIX and HP-UX
• Netscape 4.7
• Red Hat Linux 7.3
• Netscape 4.7
• Mac OSX
• Internet Explorer 5.1
• Netscape 6.2.3

Intel x86 (Pentium 400MHZ +) or compatible processor
256 MB RAM
JavaScript and cookies enabled in the browser
Java 1.4 Plug-in (www.java.com)
56K or faster Internet connection (DSL+ Recommended)