POSTER PRESENTATIONS & POSTER DISCUSSIONS
Poster Presentation with Short Oral Presentation
Short oral presentations are held on November 14 and 15 between 12:10-13:50. Speakers are asked togive the presentation to the audience using power point slides. Time provided for each presenter is 10
minutes. A consecutive interpretation (English and Japanese) is provided.

Monday, November 14, 201112:10-12:20

PP-01

12:10-13:50, Annex Hall

Yoshiharu Daiku (Eisai / JSQA)
Role of QA in the Validation (Check) of the Apparatus

12:20-12:30

PP-02

Shigeru Johki (Astellas Pharma / JSQA)
Quality Assurance for the Final Report-Making Process - How Should
We Audit the Final Report without Falling into QC Review? -12:30-12:40

PP-03

Tsutomu Kimura (Daiichi Sankyo / JSQA)
Handling of e-Data Obtained from Instruments for Quantitative Analysis

12:40-12:50

PP-04

Masaki Kudo (Nissan Chemical Industries / JSQA)
Current Status of GLP Regulations on Chemical Substances,
Pesticides and Veterinary Drugs in Japan

12:50-13:00

PP-05

Ryoichi Takeuchi (Otsuka Pharmaceutical / JSQA)
Should All Deviations Be Written in the Final Report?

13:00-13:10

PP-06

Tadahiro Yoshiyama (Chugai Pharmaceutical / JSQA)
The Appropriate Operation Controls throughout Its Life Cycle of the
System - The Suggestion of the Operational Activity of a Computerized
System after the Release -13:10-13:20

PP-07

Yasuhiro Nishi (Takeda Pharmaceutical)
A Risk-Based Approach to Conducting Sponsor's QA Audit on GLP
Facilities

13:20-13:30

PP-08

Motohiko Nishio (Yakult Honsha)
Constructing Inspection Management Databases for Reliability Criteria
Applied Studies

13:30-13:40

PP-09

Toshiki Umetani (Kyowa Hakko Kirin / JSQA)
Quality Assurance for Biotechnology - Derived Pharmaceuticals inPreclinical Safety Evaluation

13:40-13:50

PP-10

Akira Nomura (QA Advisor)
What It Is to Be QA

Tuesday, November 15, 201112:10-12:20

PP-11

12:10-13:50, Annex Hall

Daisuke Yamamoto (CAC Corporation / JSQA)
Computerized System Validation for Nonclinical Studies Leveraging
Supplier Involvement – Usage of “Cloud Computing” -12:20-12:30

PP-12

Akira Yamazaki (Kyowa Hakko Kirin / JSQA)
A Framework for Regulatory Compliance Activities for CSV andElectronic Records Management in Nonclinical Laboratories

12:30-12:40

PP-13

Yumiko Kashiwagi (Mitsubishi Chemical Medience / JSQA)Current Status of GLP Regulations on Pharmaceutical Products inJapan and Other Countries

12:40-12:50

PP-14

Yoshio Inoue (TOYAMA CHEMICAL / JSQA)
A Quality System for Clinical Sample Analysis; From the View Point ofGCP and GLP

12:50-13:00

PP-15

Shirley Wong (China GCP Consulting)
Why Are Foreign Audit Outcomes Unsatisfactory in China?

13:00-13:10

PP-16

Takahito Yamamoto (Merck Serono / JSQA)
Communication Gap Faced in the Globalization of Drug Development- What Are the Important Points for Successful Global Auditing? -13:10-13:20

PP-17

Keiichi Minato (Sparta Systems)The Expanding Role of the Quality Professional Global GMPs andGQPs and Responsibilities of Quality Professionals in the Supply
Chain

13:20-13:30

PP-18

Jyoti Sharma (Ministry of Science and Technology)
Need of Good Waste Treatment and Disposal Practices

13:30-13:40

PP-19

Hidemitsu Matsunaga (Maruishi Pharmaceutical / JSQA)
Improvement of Quality of Submission Documents in Japan - CMC,ADME, Pharmacology Studies -13:40-13:50

PP-20

Mitsuru Terajima (Kyowa Hakko Kirin / JSQA)
The Introductions and Analyses of Document-Based Inspections
Results on CMC, ADME and Pharmacology Studies

Poster Presentations
Posters are displayed during the following hours.
November 14 and 15: 9:00-17:00, November 16: 9:00-11:00

P-01

Yasuhide Kitazaki (Shin Nippon Biomedical Laboratories)
IT System Usage and the GLP Facility

P-02

Kana Kobayashi (JCL Bioassay / JSQA)
Effective Internal Facility Inspection by QAU

P-03

Kazunori Sasaki (Shin Nippon Biomedical Laboratories)
Perspectives of Archiving

P-04

Tomokazu Shigeyama (Shin Nippon Biomedical Laboratories)
Requirements and Maintenance of the SOPs in a GLP Facility

P-05

Tetsuro Sugimoto (Chugai Pharmaceutical)
Major Issues in Applying GCLP Principles to Japanese Clinical Laboratories

P-06

Emiko Takeuchi (Teijin Pharma / JSQA)
View Exchange toward Resolution of Various Problems by Oneself – Various Trials for
the Communication among Members -P-07

Bao-Long Tsai
(Taiwan Agricultural Chemicals and Toxic Substances Research Institute (TACTRI))
An Overview of GLP Implementation at TACTRI in Taiwan

P-08

Jianhui Wu (Shanghai Institute of Planned Parenthood Research)
How to Avoid Personnel of GLP to Disobey Standard Operating Procedure

P-09

Han Yan (Shanghai Institute of Planned Parenthood Research)
How to Improve the Correcting Efficiency of Study Director towards the Quality
Assurance Personnel’s Advice

P-10

Tadahiro Yoshiyama (Chugai Pharmaceutical)
Bioanalytical Instrument Qualification in GLP Laboratories That Makes Effective Use ofthe Activities of Suppliers

P-11

Elliott Graham (SQA)
SQA International Relations Committee- Global Information for the QA Professional

P-12

Elliott Graham (SQA)
Demystifying RQAP

P-13

Hannelie Carstens (International Partnership for Microbicides (IPM))
Risk Mitigation in Clinical Research in Africa

P-14

Sudheendra Kulkarni (Clinigene International)
Vendor Audits for Commercial Software

P-15

Aiko Masuda (Bristol-Myers Squibb / JSQA)
Are There Any Approvability Differences between FDA and EMA?

P-16

Koji Miyake (Dainippon Sumitomo Pharma / JSQA)
Result of a Survey by Questionnaire Concerning GCP-Relevant Computerized Systems

P-17

Shingo Ohkubo (Genzyme Japan / JSQA)
Brush up the Understanding of Risk Management for Clinical Trial

P-18

Hiroyasu Yamashita (Dainippon Sumitomo Pharma / JSQA)
Global Discussion Project for Supplements of GCQA Guideline for GCP Auditing

P-19

Hiroshi Yonezawa (Taiho Pharmaceutical / JSQA)
Present State of Methods for Documenting Informed Consent in Japan

P-20

Hiroshi Shigeno (UCB Japan / JSQA)
Appropriate Product Quality Information Handling Based on Japanese Good Quality
Practice Rule, and Effective Usage of PC System

P-21

Toshiro Asahina (Merck Serono /JSQA)
Mission of Our International Affairs Committee

P-22

Chihiro Ishizuka (Toray Industries / JSQA)
Education System of JSQA

Poster Discussions
Standard poster presenters will stand by their posters between 13:30 - 14:00, either on November 14
and 15 to answer questions from participants.

Monday, November 14, 2011

13:30-14:00, Annex Hall

Poster with Short Oral Presenters;
PP-11

Daisuke Yamamoto (CAC Corporation / JSQA)

PP-12

Akira Yamazaki (Kyowa Hakko Kirin / JSQA)

PP-13

Yumiko Kashiwagi (Mitsubishi Chemical Medience / JSQA)

PP-14

Yoshio Inoue (TOYAMA CHEMICAL / JSQA)

PP-15

Shirley Wong (China GCP Consulting)

PP-16

Takahito Yamamoto (Merck Serono / JSQA)

PP-17

Keiichi Minato (Sparta Systems)

PP-18

Jyoti Sharma (Ministry of Science and Technology)

PP-19

Hidemitsu Matsunaga (Maruishi Pharmaceutical / JSQA)

PP-20

Mitsuru Terajima (Kyowa Hakko Kirin / JSQA)

Standard Poster Presenters;
P-01

Yasuhide Kitazaki (Shin Nippon Biomedical Laboratories)

P-03

Kazunori Sasaki (Shin Nippon Biomedical Laboratories)

P-05

Tetsuro Sugimoto (Chugai Pharmaceutical)

P-07

Bao-Long Tsai (TACTRI)

P-09

Han Yan (Shanghai Institute of Planned Parenthood Research)

P-13

Hannelie Carstens (International Partnership for Microbicides (IPM))

P-15

Aiko Masuda (Bristol-Myers Squibb / JSQA)

P-17

Shingo Ohkubo (Genzyme Japan / JSQA)

P-19

Hiroshi Yonezawa (Taiho Pharmaceutical / JSQA)

Tuesday, November 15, 2011
Poster with Short Oral Presenters;
PP-01

Yosh iharu Daiku (Eisai / JSQA)

PP-02

Shigeru Johki (Astellas Pharma / JSQA)

PP-03

Tsutomu Kimura (Daiichi Sankyo / JSQA)

PP-04

Masaki Kudo (Nissan Chemical Industries / JSQA)

PP-05

Ryoichi Takeuchi (Otsuka Pharmaceutical / JSQA)

PP-06

Tadahiro Yoshiyiama (Chugai Pharmaceutical / JSQA)

PP-07

Yasuhiro Nishi (Takeda Pharmaceutical)

PP-08

Motohiko Nishio (Yakult Honsha)

PP-09

Toshiki Umetani (Kyowa Hakko Kirin / JSQA)

PP-10

Akira Nomura (QA Advisor)

13:30-14:00, Annex Hall

Standard Poster Presenters;
P-02

Kana Kobayashi (JCL Bioassay /JSQA)

P-04

Tomokazu Shigeyama (Shin Nippon Biomedical Laboratories)

P-06

Emiko Takeuchi (Teijin Pharma / JSQA)

P-08

Jianhui Wu (Shanghai Institute of Planned Parenthood Research)

P-10

Tadahiro Yoshiyama (Chugai Pharmaceutical)

P-11

Elliott Graham (SQA)

P-12

Elliott Graham (SQA)

P-14

Sudheendra Kulkarni (Clinigene International)

P-16

Koji Miyake (Dainippon Sumitomo Pharma / JSQA)

P-18

Hiroyasu Yamashita (Dainippon Sumitomo Pharma / JSQA)

P-20

Hiroshi Shigeno (UCB Japan / JSQA)