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Biographies, Presentations, and Presentation Abstracts – USP Annual Scientific Meeting 2009

Agenda  (73KB)

Adulteration and Contamination: Technologies of the Future Resolution 3 Advisory Panel General Session (open to all ASM attendees)

Opening General Session

  • Board of Trustees Update: Duane M. Kirking, Pharm.D., Ph.D., USP Board of Trustees, Presentation  (725KB)
  • USP Update: Roger L. Williams, M.D., Chief Executive Officer, USP Presentation  (681KB)

Canadian Food and Drug Regulation

Session I/Track I: Quality of Manufactured Medicines – Supply Chain Management Regulatory Perspective

Session I/Track II: Quality of Manufactured Medicines – Measurement Science Advanced Analytical Technologies

Session I/Track III: Quality of Manufactured Medicines – Biologics & Biotechnology Process and Ancillary Materials

  • Ancillary Materials in Cell Manufacturing: Fouad Atouf, Ph.D., Scientist: Presentation  (574KB)
  • Biologics & Biotechnology: USP and Anthony Ridgway  (11KB), Ph.D., Member, USP B&B-Cell, Gene and Tissue Therapy Expert Committee
  • Reagents Used in Cell Manufacturing: Thomas Montague, BD Biosciences - Advanced Bioprocessing, Presentation  (569KB)
  • Qualification of Ancillary Materials (e.g. Fetal Bovine Serum): John Harrington  (9KB), Life Technologies, Presentation  (733KB)
  • Raw Material Testing: Marina Kirkitadze  (10KB), Ph.D., Sanofi Pasteur, Abstract  (46KB), Presentation  (4.9MB)

Session I/Track IV: Quality of Manufactured Medicines – New Compendial Initiatives Performance Based Monographs

Session I/Track V: Quality of Food Ingredients (One Day Offering) – International Food Ingredient Safety Issues Workshop

Session II/Track I: Quality of Manufactured Medicines – Supply Chain Management International Supply Chain Management

Session II/Track II: Quality of Manufactured Medicines – Measurement Science (Combined Session with Biologics & Biotechnology)

Session II/Track III: Quality of Manufactured Medicines – Biologics & Biotechnology and Measurement Science (Residual DNA Testing)

Session II/Track IV: Quality of Manufactured Medicines – New Compendial Initiatives (General Chapters of the Future)

  • Stimuli Article and Industry Perspective—General Chapters Project Team: Phyllis Walsh  (10KB), MBA, Schering Plough Corporation, Presentation  (592KB)
  • Procedural Standards, Ancillary Materials: Tina Morris, Vice President, Biologics & Biotechnology, USP, Presentation  (2.1MB)
  • Route of Administration Chapters: Vinod Shah  (10KB), Ph.D., USP Consultant, Abstract  (45KB), Presentation  (410KB)
    • Default Monograph Chapters
    • Performance Verification Chapters
    • Informational Chapters

Session II/Track V: Quality of Food Ingredients (One Day Offering) – International Food Ingredient Safety Issues Workshop

  • Food Security (Bioterrorism): Frank Busta  (9KB), Ph.D., University of Minnesota, Abstract  (45KB), Presentation  (9MB)
  • Food Import Safety, U.S. Perspective: Richard Chiang, FDA, Presentation  (1.4MB)
  • Food Import Safety, Canada Perspective: Matthew Bauder, Health Canada, Presentation  (969KB)

Interactive General Session—Biomeasurement

  • Canada: National Research Council: James McLaren, Ph.D., Presentation  (1.5MB)
  • China: National Institute of the Control of Pharmaceuticals and Biologics: Junzhi Wang  (32KB), Ph. D., Abstract  (45KB), Presentation  (2.9MB)
  • United Kingdom: National Institute for Biological Standards and Control: Adrian Bristow  (10KB), Ph.D., Abstract  (57KB), Presentation  (2.7MB)
  • United States: National Institute of Standards and Technology: Marc Salit, Ph.D., Presentation  (1.2MB)

Session III/Track I: Quality of Manufactured Medicines – Supply Chain Management (Anti-counterfeiting/Adulteration)

  • Health Canada and WHO Anti-counterfeiting Initiatives: Jean Saint-Pierre, Health Canada, Presentation  (1.1MB)
  • Progress Towards Establishing E-pedigree for Drugs: Michael N. Eakins  (10KB), Ph.D., Vice Chair, USP Packaging & Storage Expert Committee, Abstract  (45KB), Presentation  (322KB)
  • Online Medicine – Cost-effective Healthcare/Fundraiser for Global Cyber Crime: James Thomson, Center for Mental Health Presentation  (15.5MB)

Session III/Track II: Quality of Manufactured Medicines – Measurement Science (Combined Session with Biologics & Biotechnology)

Session III/Track III: Quality of Manufactured Medicines – Biologics & Biotechnology and Measurement Science (Monographs and Reference Standard Modernization)

Session III, Track IV: Quality of Manufactured Medicines – New Compendial Initiatives (General Notices—Revision 2009)

Session III, Track V: Quality of Food Ingredients – GMPs

Session IV, Track I: Quality of Manufactured Medicines – Supply Chain Management Transportation

  • Revision to Health Canada’s Guidelines for Temperature Control of Drug Products During Storage and Transportation: Sarah Skuce  (10KB), Health Canada, Abstract  (45KB), Presentation  (369KB)
  • Revision to USP <1079> Good Storage ad Shipping Practices: Mary G. Foster, Pharm.D., Member, USP Packaging & Storage Expert Committee, Presentation  (816KB)
  • Air Transport Logistics for Time and Temperature Sensitive Healthcare Products: Meeting the Requirements of the New International Air Transport Association Regulations, Kevin O’Donnell, Tegrant Corporation, Presentation  (844KB)

Session IV, Track II: Quality of Manufactured Medicines – Measurement Science (Metrological Traceability and Equivalent or Better)

Session IV, Track III: Quality of Manufactured Medicines – Biologics & Biotechnology (Analytical Characterization)

Session IV, Track IV: Quality of Manufactured Medicines – New Compendial Initiatives Compendial Processes in the 2010-2015 Cycle

  • USP Bylaws and Rules and Procedures of the Council of Experts: Susan S. de Mars  (14KB), J.D., Chief Documentary Standards Officer/General Counsel, USP, Presentation  (365KB)
  • Preparation for the 2010-2015 Cycle and "Design Phase" Approaches to Standards-setting: Angela G. Long, Vice President, Volunteer and Organizational Affairs, USP, Presentation  (319KB)
  • Expert Committee Recruitment: Nelufar Mohajeri  (9KB), Director, Volunteer Affairs, USP, Presentation  (1001KB)
  • Stakeholder Perspective: Joseph Garber  (9KB), Astra-Zeneca, Presentation  (390KB)

Session IV, Track V: Quality of Food Ingredients (Functionality)

General Session: Nanotherapeutics and Measurement

  • Overview: Todd L. Cecil, Ph.D., Vice President, Compendial Sciences, USP, Presentation  (1.5MB)
  • Therapeutics: Maria Foldvari  (9KB), D.Pharm.Sci., Ph.D., Canada Research Chair in Bionanotechnology and Nanomedicine, Abstract  (44KB), Presentation  (14.5MB)
  • Environment: Scott McNeil  (10KB), Ph.D., Director, Nanotechnology Characterization Lab, SAIC, Abstract  (69KB), Presentation  (1.3MB)

Closing General Session