Institute for International Research

This page will be used to provide paid delegates of the conference with access to any presentations that were not included in the conference documentation. Only paid conference delegates have permission to access IIR online documentation.

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9:00am
Implementing Quality by Design Concepts in the Analytical Laboratory for Improved Product Quality
Mark D. Mowery, Associate Director, Analytical Development, PATHEON PHARMACEUTICALS

11:30am
Keynote Session: The Use of Exploratory INDs and Other Initiatives to Expedite Drugs to the Market
Linda Storbeck, Director of Technology Regulatory Affairs, MDS PHARMA

1:45pm
An Overview of the Regulations and Approaches to Address Genotoxic Impurities
• Available Regulatory Guidance
• PhRMA White Paper / Publications
• CMC Regulatory Perspective
• Regulatory Safety Perspective
• Approaches to understanding and quantifying genotoxic impurities.
• Discussion: What to expect in the future Dr.

Suzanne Thornton-Jones, Regulatory Biosafety, SANOFI-AVENITS

3:45
Sharing Strategies on Global Submissions to Help Minimize Unnecessary Time and Resources

Moderator:
Gail Owens, US and Global Project Leader, Regulatory Affairs CMC, SANOFI-AVENTIS

Panelists:
Mary Vanderkauter, Manager – Regulatory CMC, PHARMION
Jim Segretario, Regulatory Affairs/Global, ABBOTT LABORATORIES
David Ziering, Director, Global Regulatory Sciences CMC, BRISTOL-MYERS SQUIBB

4:30
Panel Discussion on How the Restructuring at the FDA is Affecting How Submissions are Reviewed and How they Need to be Submitted

Moderator:
Duu-Gong Wu, PhD, Executive Director, Consulting Division, PHARMANET (Former deputy division director of Division of New Drug Chemistry II, Office of New Drug Chemistry in CDER, chemistry team leader and reviewer for the Food and Drug Administration)

Panelist:
David T. Lin, PhD, Senior Consultant, BIOLOGICS CONSULTING GROUP, INC. (Former Division Director New Drug Chemistry III, Office of New Drug Chemistry – CDER, FDA)

9:15am
USP Session Meeting Worldwide Compendial Requirements
Todd L. Cecil, PhD., Vice President, STANDARDS DEVELOPMENT USP

11:15am
Clarifying and Understanding ICH Guidance to Help Meet International Requirements for Submissions
David T. Lin, PhD, Senior Consultant, BIOLOGICS CONSULTING GROUP, INC. (Former Division Director New Drug Chemistry III, Office of New Drug Chemistry – CDER, FDA)

10:00am
Exploring the Options for Responses to Deficiency Letters in the US and EU to Help Expedite Approval
Jim Segretario, Global Regulatory Affairs, ABBOTT LABORATORIES