Morgan Lewis

Regulatory Process — Navigating the FDA: Moving from Product Concept to Product Clearance/Approval (Spring Training Briefing Series) Pittsburgh

  • date(s):

    April 25, 2008 8:00 AM
    - April 25, 2008 9:45 AM

  • location:

    Pittsburgh

related attorney(s):

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This briefing will deliver to life sciences executives the regulatory processes involved in taking a product from the development stage to market. Topics will be presented in a practical, hands-on manner. Areas addressed include determining product jurisdiction and the optimal regulatory pathway; managing preclinical and clinical study requirements; and preapproval promotion issues. In addition, the briefing will focus on a critical stage for all companies: interacting with the FDA. This will include best practices for FDA meetings, strategies for addressing scientific disputes, and preparation for panel meetings.

Presented by:
Morgan Lewis Partner Elizabeth Bierman and
Dr. Sharon Segal, Director of Regulatory Science

Agenda:
8:00am - 8:30am: Registration and breakfast
8:30am - 9:45am: Program

Location:
Pittsburgh Life Sciences Greenhouse
100 Technology Drive, Suite 400
Pittsburgh, PA 15219

RSVP to:
Steve Perdziola at 412.560.7786 or sperdziola@morganlewis.com

The Spring Training Briefing Series

Morgan Lewis, in cooperation with the Pittsburgh Life Sciences Greenhouse, has developed a series of practical, "from the dugout" briefings, exclusively for life sciences company executives in the Pittsburgh region. The Spring Training Series offers three monthly briefings, which will provide life sciences company executives with a solid grounding in the core issues, practical real-world examples, and a wealth of resource material. Briefings will be led by a lineup of Morgan Lewis partners, in concert with industry executives.

The Series: