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    PPG inc.

    973-11 Hongo-cho, Kita-ku, Saitama city, Saitama, Japan 331-0802
    TEL +81-48-676-0774


External activity/Presentations


●Future external activity/presentations

Please refer top page


Former Presentations and Journals 

●Presentations

2012.1.25

Writing and dossie creation for PMDA NDA(Technical information institute co. ltd.

2012.2.13

Process management and internal collaboration on NDA(Science and Techonology)

2012.1.27

How to Create J-NDA(Johokiko Co., Ltd)

2012.1.25

Preparation of eCTD submission and eCTD Quality (JSQA)

2011.11.16

MIST Jam 2011 ; Current status of eCTD and ER/ES

2011.9.29-30

Streamline submission activity for early approval(Science and Technology)

2011.8.31

Point of consider for NDA(Johokiko Co., Ltd.
2011.7.15 Key Note Speach on LIQUENT-eSA Workshop in Tokyo
2011.6.30 Risk and Crisis Management on Pharmaceutical company(Science and Technology)
2011.5.30 Know How for NDA documentation and PMDA consultation(Technical information institute co. ltd.)
2011.5.23 Point of consideration of eCTD implementation and actual process of eCTD submissione (Johokiko Co., Ltd.)
2011.4.18 Outsourcing and considerations on eCTD submission
(Science and Technology)
2011.2.8

Guideline of secure management for the Medicinal information;8th MIST Symposium

2010.12.2 M2:ESTRI; ICH Japan Symposium2010
2009.12.4

Necessity of computerization on Pharmaceutical development and current considerations; JPMA Electronic Standard sub-committee symposium

2009.11.20 Current status of electronic submission on Pharmaceutical industry and ICH activity; 3rd Three S Japan Seminar
2009.10.22-23
Direction of Computerization in Pharmaceutical Development; The 6th Annual Japan DIA Meeting
2009.6.25 JPMA electronic Intermediate standard for data exchange, Information management group on medical school hospitals in Takamatsu
2009.6.12 M2 (eCTD): ICH Japan Symposium2009
2009.2.4

Point of consideration for necessity of computerization on Pharmaceutical industry;JPMA Electronic information sub-committee symposium(CTN and eCTD)

2008.12.4 Computerization of pharmaceutical industries; #9 DDWorks21 Users Meeting
2008.11.25 Current situation of computerization on Pharmaceutical development;  4th MIST symposium
2008.3.6 Electronic standard for common document formats on GCP, 3rd MIST Symposium
2004.6.24-25 eCTD Japanese Local Guidance: 5th Annual Workshop in Japan for Medical Information Processing DIA
1995 Increasing of Sensitivity of Primary amine and Hydroxyl group for LC/APCI-MS by acetyl; The Japan Society for Analytical Chemistry the 44th Annual Meeting
1995 Development of LIMS (laboratory information management system)(2); The Pharmaceutical Society of Japan the 115th Annual meeting
1994 Increasing of Sensitivity for LC/APCI-MS by Using Semi-micro Column; The Japan Society for Analytical Chemistry the 43rd Annual Meeting
1994 Force Degradation Stability Study of KE-298; The Pharmaceutical Society of Japan the 114th Annual meeting
1993
Force Degradation Stability Test of TS-110 No.2 –Ddegradation Pathway and Degradation Product Structures in Solution-; The Pharmaceutical Society of Japan the 113th Annual meeting
1992 Determination of Vitamin D’s by LC/MS; The Japan Society for Analytical Chemistry 41st Annual Meeting
1992 Determination of Prostaglandins by LC/APCI-MS; 9th Discussion Meeting for Chromatography



●Journals and Papers

2011 Why do we need ER/ES guidance?, Clinical Research Proffeionals No.25 (8) .
2010 Direction of computerization for pharmaceutical development; Rinsyo-Iyaku, 26(4) : 261-272
2009 Electronic record of medicinal information and Computerization of clinical study #3 Current status and future consideration on computerization of Pharmaceutical company, Clinical Research Proffeionals No.12 (6) , 50-59.
2009 ESTRI Topics M2(eCTD):Iyakuhin Kenkyu Vol.40 (10), 670-672
2006
平成17年度治験推進研究事業研究報告書 − 治験IT 化の現状と課題 「治験 IT 化の現状と課題(PDFファイル)」(研究協力者)
2005 平成16年度厚生労働科学特別研究事業「次世代医療機器研究・開発・商業化
促進のための薬事承認の在り方に関する研究治験の電子化に関する調査研究」「治験電子化に関する調査研究班(PDFファイル)」(研究協力者)
1997 Effect of water content and temperature on the stability of lornoxicam tablets: Drug Stability, 4, 202-208
1996 Degradation products and pathway of lornoxicam in aqueous solution: Drug Stability, 1, 166-172
1996 Increasing of sensitivity by Acetylating derivatization on High-Performance Liquid Chromatography/Atmospheric Pressure Chemical Ionization Mass: Bunseki Kagaku, 45(6)(日本分析化学会), 501-504
1995
Improvement of dissolution characteristics of 4-t-butyl-2’carboxymethoxy-4’-(3-methyl-2-butenoyloxy) chalcone by b-cyclodextrin complex: Eur. J. Pharm. Sci, 3, 323-328
1995 Improvement of Dissolution Characteristics of New Chalcone Derivative, SU-740:Comparison between Size Reduction, Solid Dispersion and Inclusion Complexation: Chem. Pharm. Bull, 43(12), 2221-225
1995 Method of increasing sensitivity of liquid chromatography-atmospheric pressure chemical ionization mass spectrometry using a semi-micro column: J. Chrom. A, 715, 13-18
1995 Degradation kinetics of KE-298 and chelating ability of its degradation products:  Int. J. Pharm., 124, 129-135
1994 Determination of Vitamin D3 and D2 in Multi-Vitamin tablets by High-Performance Liquid Chromatography/Atmospheric Pressure Chemical Ionization Mass Spectrometry: Anal. Sci., 10, 457-460
1994
Determination of Prostaglandins by High-Performance Liquid Chromatography/Atmospheric Pressure Chemical Ionization Mass Spectrometry: Bunseki Kagaku, 43, 189-194

Note: Some parts are Japanese only (difficult for English translation)