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02N-0518: Preparation for International Conference on Harmonisation Meetings in Tokyo, Japan, Including Progress on Implementation of the Common Technical Document and Update on New Topics
Item Code
No.
Received Date
Submitter
Signature
FR Date
FR Page
Electronic Format
TR 1 02/04/03 Transcript of the January 21, 2003 meeting             pdf , htm

Word

REF 5 02/04/03 U S Patent 6,205,455           pdf
REF 4 02/04/03 U S Patent 5,963,967            pdf
REF 3 02/04/03 U S Patent 5,734,883            pdf
REF 2 02/04/03 U S Patent 6,505,218            pdf
REF 1 02/04/03 Press Release Patent Covering eCTD Awarded to Michael Umen & Co., Inc.       pdf , htm

Word

C 2 02/04/03 Eli Lilly Company Pat Mooney        ppt
TS 9 02/04/03 Update from the MSSO             ppt , htm
TS 8 02/04/03 HFM-591, Gene Therapy Branch, Division of Cellular & Gene Therapies, Center for Biological Evaluation and Research, FDA Stephanie Simek        ppt

htm

ICH V1, An FDA Update
TS 7 02/04/03 HFD-430, Office of Drug Safety, Center for Drug Evaluation and Research, FDA Susan Lu        ppt

htm

ICH V2, An FDA Update
TS 6 02/04/03 HFD-430, Office of Drug Safety, Center for Drug Evaluation and Research, FDA Min Chen, M.S., RPh        ppt

htm

ICH V1, An FDA Update
TS 5 02/04/03 HFD-1, Center for Drug Evaluation and Research, FDA Justina A. Molzon, M.S. Pharm., J.D.       ppt

htm

The Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
TS 4 02/04/03 ICH M2 Deputy Topic Leader Jon Clark       

ppt

htm

 
Electronic Common Technical Document (eCTD) Update
TS 3 02/04/03 Office of International Programs, FDA Christelle Anquez       

ppt

htm

 
Implementation Status of the CTD in the Other ICH-Regions: Europe, Japan and Canada
TS 2 02/04/03 HFD-1, Center for Drug Evaluation and Research, FDA Justina A. Molzon, M.S. Pharm., J.D.       

ppt

htm

 
FDA Perspective Implementation Status of the CTD
TS 1 02/04/03 Christelle Anquez Christelle Anquez        ppt

htm


"Overview of ICH: A description of the structure and Harmonization Process"
C 1 01/21/03 AstraZeneca  Carol Stinson-Fisher         pdf
LST 1 01/13/03 Agenda of the 01/21/2003 meeting             Word, pdf
NM 1     Notice of Meeting     01/02/2003 126 htm, pdf

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Page last updated March 2, 2004

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