Presentations
Public Dissemination of Information About Investigational Products
8:30-10:00 am | Gold Room, Lobby Level
Presented by:
Joyce L. Chiarenza, Chiarenza Consulting LLC
Brian R. McCormick, Hogan & Hartson LLP
Paul F. O’Connor, Almac Clinical Services
Mitigating Potential Liability Issues From New Technologies
10:30 am-12:00 pm | Gold Room, Lobby Level
Presented by:
Matthew T. Heartney, Arnold & Porter LLP
Saul B. Helman, Navigant Consulting Inc
How to Avoid the Ten Biggest Mistakes Companies Make When Meeting With FDA District Offices
1:30-2:30 pm | Gold Room, Lobby Level
Presented by:
Barbara J. Cassens, US Food and Drug Administration
Ronald M. Johnson, Ron Johnson’s Compliance Services
Navigating the Gray Zone: Decision Making When Requirements Aren't Identified
1:30-2:30 pm | Venetian Room, Lobby Level
Presented by:
William H. Cover, Allergan Incorporated
Steven A. Kradjian, Conventus Biomedical Solutions Inc.
Alan G. Minsk, Arnall Golden Gregory LLP
Negotiations and Partnering With Other Disciplines
1:30-2:30 pm | Terrace Room, Terrace Level
Presented by:
Daniel G. Mannix, Bristol-Myers Squibb Company
William J. Neubert, Covidien Imaging Solutions
Utilizing Summary Technical Document (STED) Format for Global Device Submissions
3:00-4:00 pm | Gold Room, Lobby Level
Presented by:
Osamu Doi, Society of Japanese Pharmacopoeia
William F. Greenrose, Qserve America Inc.
Chie Iwaishi, Cordis Corporation
Shigeki Tsuda, Society of Japanese Pharmacopeia
Regulatory Strategies for Combination Products: How to Make Everyone Happy
3:00-4:00 pm | French Room, Lobby Level
Presented by:
William H. Cover, Allergan Incorporated
Alan G. Minsk, Arnall Golden Gregory LLP
CTD Language and Translation Requirements
3:00-4:00 pm | Terrace Room, Terrace Level
Presented by:
Taylor Burtis, Novelos Therapeutics Inc.
Elizabeth A. Ferguson, Parexel Consulting
Michelle Perez, Image Solutions Inc.
Implementing Access to the Electronic Secure Gateway (ESG):
A Small to Mid-Size Company Perspective
3:00-4:00 pm | Venetian Room, Lobby Level
Presented by:
Michael B. Fauntleroy, US Food and Drug Administration
Reuben K. Jenkins, Ominicia Incorporated
Utilizing Clinical Trials to Foster Payer Adoption
4:00-5:00 pm | Terrace Room, Terrace Level
Presented by:
Kimberly K. Norton, Argenta Reimbursement Advisors LLP
Unapproved (Off-Label) Indications
4:00-5:00 pm | Venetian Room, Lobby Level
Presented by:
Douglas B. Farquhar, Hyman Phelps & McNamara PC
Eric D. Hargan, McDermott Will & Emery
Management of the Q&A Review Process Between Sponsor and Reviewer
4:00-5:00 pm | Gold Room, Lobby Level
Presented by:
Linda D’Abate, The Weinberg Group Inc.
Lawrence J. Grylack, Parexel International
Matthew G. Hillebrenner, US Food and Drug Administration