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Baltimore Marriott Inner Harbor at Camden Yards

Apr 03, 2013 8:15 AM - Apr 04, 2013 5:00 PM

110 South Eutaw Street, Baltimore, MD 21201-1608

Regulatory Information Management 2013

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Session 8A: Business Track - Implications of Working with FDA under FDASIA: A Primer for Successful Planning, Submission, and Approval of Applications

Session Chair(s)

Lisa Jenkins, PhD, MS

Lisa Jenkins, PhD, MS

Vice President, Regulatory Strategy and Content Development

Virtual Regulatory Solutions, Inc, United States

In 2012, FDASIA (including PDUFA V, MDUFA III, and GDUFDA) was signed into law. This session describes and interprets the new provisions from an FDA and Industry perspective and makes strategic recommendations for multiple disciplines.

Speaker(s)

Kimberly Belsky, MS

Presenters

Kimberly Belsky, MS

Independent, United States

Reg Policy & Intell and AdPromo, Regulatory Affairs

Ronald Trust, PhD, MBA

Presenter

Ronald Trust, PhD, MBA

Pharmexpertise, LLC, United States

Independent Consultant

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