Presentations
Business Strategic Role of the Regulatory Professional
10:30 am-12:00 pm | Gold Room, Lobby Level
Presented by:
Jim W. Birchenough, Lehman Brothers
Alison F. Lawton, Genzyme Corporation
Navigating the Product Development Process
1:30-2:30 pm | Terrace Room, Terrace Level
Presented by:
Joan M. Centofanti, Centofanti Consulting Inc.
Defining Where Research Ends and Design Controls Begin
1:30-2:30 pm | Venetian Room, Lobby Level
Presented by:
Denise D. Dion, EduQuest Inc.
Lourdes V. Valentín-Aponte, Schering Plough
Regulatory Strategy When Outsourcing Global Clinical Trials
1:30-2:30 pm | Gold Room, Lobby Level
Presented by:
Meredith Brown-Tuttle, V2 Bio-Consultants
Karen Jones, Genentech
Carla Kikken-Jussen, MediTech Strategic Consultants BV
Developing Regulatory Strategy
3:00-4:00 pm | Terrace Room, Terrace Level
Presented by:
William F. Greenrose, Qserve America Inc.
Jane A. Moffitt, Regulatory Consultant
Risk Management With New Technologies
3:00-4:00 pm | Venetian Room, Lobby Level
Presented by:
Heinz J. Steneberg, Medtronic Inc.
Alford R. Taylor Jr., US Food and Drug Administration
Mapping Out Preclinical and Human Studies to Support Safety:
Getting to First-in-Man Clinical Trials
3:00-4:00 pm | Gold Room, Lobby Level
Presented by:
Ian Millett, Cook Inc.
Quality by Design: An Attempt to Jumpstart Innovation in the Manufacturing Process
4:00-5:00 pm | Terrace Room, Terrace Level
Presented by:
Peter H. Calcott, Calcott Consulting
Managing Use Error Risk: Human Factors Methods in the Design Controls Process
4:00-5:00 pm | Venetian Room, Lobby Level
Presented by:
Robert A. North, Human Centered Strategies LLC
Time to Market Planning for a New Chemical Entity (NCE) Submission for Drugs
4:00-5:00 pm | Gold Room, Lobby Level
Presented by:
Sally L. Anliker, Eli Lilly and Company
Gretchen M. Bowker, Safis Solutions