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  • The Orange Book blog team are a group of attorneys with McAndrews, Held and Malloy, which is a full-service IP firm representing both brands and generics in various aspects of IP law. This blog does not provide legal advice. If you are seeking legal advice, please contact the author directly.

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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. The views expressed are solely those of the authors, and may not reflect the views of MHM or its clients. No part of Orange Book Blog--whether information, commentary, or other--may be attributed to MHM or its clients. MHM represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MHM clients. Orange Book Blog will always strive to be unbiased. All information on Orange Book Blog should be double-checked for its accuracy and current applicability.

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July 05, 2007

ACI "FDA Boot Camp" Conference, Boston, July 17-18

American Conference Institute's popular "FDA Boot Camp" comes to Boston on July 17-18.  According to ACI, seats at this year's New York and last year's Chicago editions sold out.

The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts "a strong working knowledge of core FDA regulatory competencies."  The conference features top FDA regulatory experts from pharmaceutical companies and outside law firms.

Presentations on the agenda include:

  • The Basics: Understanding and Working with the FDA--Jurisdiction, Functions, Organization, and Operations
  • The Nature of the Approval Process
  • Understanding the Clinical Trial Process for Drugs and Biologics
  • Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More
  • Drugs and Biologics: Labeling
  • Medical Devices: Classification and the Essentials of the Device Premarket Review Process

The chair for the conference is Michael P. Peskoe of Edwards Angell Palmer & Dodge LLP.  Additional details and registration information are available at the conference website.

Orange Book Blog is a media partner of this conference.

Posted by in Conferences |

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