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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 3A: Business Track - Global Product Classification: Identifying Challenges in Registration & Approval

Session Chair(s)

Kimberly Belsky, MS

Kimberly Belsky, MS

Reg Policy & Intell and AdPromo, Regulatory Affairs

Independent, United States

Companies may seek to bring their products to new global markets during the initial approval process or post-approval process. Leveraging a US dossier may present unanticipated challenges since the classification of a product and dossier requirements may change in the target country or region. This session will explore the challenges of geographic expansion and provide points to consider when planning the regulatory strategy and potential roadblocks.

Speaker(s)

Brooke Casselberry, MS, RAC

Presenter

Brooke Casselberry, MS, RAC

Epista Life Sciences, United States

Vice President, Advisory and Delivery

Mary Jane Nehring, MBA

Presenter

Mary Jane Nehring, MBA

Bausch & Lomb, United States

Executive Director, International Regulatory Affairs

Lauren Quinn, JD

Presenter

Lauren Quinn, JD

Novartis Consumer Health, Inc., United States

Head of US Regulatory Affairs

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