Thank you for your submission of abstract!!!
The Oral, Poster with short oral and Poster presentation submission had been closed.

 

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Schedule & Session Topics 　 ／　How to apply 　　　　

Rules

     *      Abstract must be submitted only via the website.  E-mail and facsimile will not be accepted.
     *      Carefully fill out all the fields of the abstract form.
     *      Please note that one person can submit ONE abstract. 
             If you prefer to submit both oral and poster presentations, you are requested to submit these abstracts separately.
     *      When submission is completed, you will automatically receive the confirmation of receipt of your abstract submission
             with your abstract submission number.  This number should be quoted in all abstract correspondence. 
             Please keep a note of this number.
             If you do not receive this e-mail within 1 day of your submission, please contact the 3rdGQAC Secretariat Office by e-mail.
     *      Once authors submit their abstract, you cannot update or correct your information and abstracts. 
             In case you need to modify them, please contact the 3rdGQAC Secretariat Office by e-mail.
     *      All abstracts for oral and poster presentation will be published in the Conference Abstract Book and distributed to attendees.

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Schedule of Abstract Submission

2011
February 1	Start for Calling for Abstracts
April 30   May 13	Deadline for Abstract Submission (Oral presentation) Deadline for Abstract Submission (Poster with short oral presentation)
June	Notification of the Review Result of Submitted Abstracts
July 31	Deadline for Abstract Submission (Poster presentation)
August 31	Deadline for Early Registration
September 30	Deadline for Presentation Submission (Oral presentation and poster presentations with short oral presentations)

 

 

 

Presentation Format

     *      Please see the abstract sample of here.
     *      Abstract body should contain a maximum of 300 words and must be submitted in English.
     *      No chart or graphics should be included in the abstract.
     *      All abstracts will be reviewed by the program committee.
     *      All authors will be notified by e-mail of the review of their abstract.

 

Oral Presentations

Submission of the oral presentations will be available either at the Concurrent Sessions
or at the Pre-Conference Symposium.
In either case, those who wish to submit for oral presentations have to choose the appropriate session topics.

The session topics are as follows:

◆ Quality Assurance for Electronic Records in Non-clinical Laboratories

This session focuses on the topics as follows, * Computerized System Validation throughout System Life Cycle * Electronic data management in Non-clinical Studies * Approach for long-term retention of electronic records. This session would be consisted of some lectures or oral presentations and a panel discussion.

◆ International Perspective of Pathology Peer Review

The pathology peer review system is one of critical issues. Recently the pathology peer review system has been discussed internationally. In this session, participants understand and also can be actively involved in discussions for current status of the pathology peer review system in each country.

◆ Good Clinical Laboratory Practice (GCLP) / Incurred Sample Reanalysis (ISR)
◆ QA versus QC
◆ International Interpretation of GLP

If you wish to present in the oral session on the topics of "GCLP/ISR", "QA vs QC", and "International Interpretation of GLP", you may probably have some 20 min for your talk.

 

◆ CDISC Makes You Happy!   -Current & Future of Clinical Data Standards-  Pre-Conference Symposium (November13)

CDISC (Clinical Data Interchange Standards Consortium) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC is not just for submission standards, it is also useful in the clinical trial process for all stakeholders. In this session, we would like to share the values of CDISC, what brings benefits from the CDISC.

◆ Discuss GCP Compliance Clinical Trial from the “Risk” Standpoint

We will share and re-organize the risk area knowledge body on clinical trial. Expected discussion as follows. - Re-organization of the risk detection and the management strategy on the clinical trial. - Diversities of the risk management strategy from the various stakeholders standpoints. - Comparison of the risk management strategy among US, EU, Japan and other countries

◆ Quality Control and Quality Assurance in Japan
   - Quality Control and Quality Assurance in the Future (Toward Next Generation) -

The pharmaceutical companies in Japan, generally organize a section specialized for quality control and assign staff. We, JSQA would like to introduce the history and present situation in Japan. Various presentations and ideas from different regions (US, EU, Japan and other countries) will be hoped. We would like to think together the ideal quality assurance system.

 

◆ Pharmacovigilance (PV) Regulation

This session intends to explore differences among Japan, U.S. and Europe in the regulatory requirements and inspections for post-marketing PV and Japanese post-marketing surveillance.

◆ PV Quality Assurance

This session intends to present and discuss each company's audit and self-audit approaches for assuring the reliability of PV process (data collection, data assessment, communication or outsourcing for PV) and points to be noted. Japanese unique concept/method of self-audit also will be discussed.

◆ PMS Quality System

This session intends to present and discuss each company's audit and self-audit approaches for assuring the reliability of PMS process (study plan, study implementation, data management, data analysis and outsourcing) and points to be noted. PMS: Post Marketing Study

◆ GMP and/or GQP Regulation

This session intends to recognize differences in the regulations among Japan, U.S. and Europe based on the GMP regulation topics in Japan, U.S. and Europe or Japanese unique regulatory requirements for GQP. GQP: Good Quarity Practice

◆ ICH Q Trio Approach Laboratories

This session intends to discuss the system and methods for assuring the reliability of ICH Q trio (Q8, Q9, and Q10) by exploring the ICH Q trio approaches taken by each company.

 

◆ GMP for IMP/INDs

If you wish to present in the oral session on the topics of "GMP for IMP/INDs", you may probably have some 20 min for your talk.

 

Poster Presentations: Any topics will be acceptable

  Poster Presentation Styles;

◆ Poster with short oral presentations
     The Poster sessions will be held 12:00 - 14:00 (14 and 15), November 2011
      Poster sessions will provide poster presenter with an opportunity to orally present her/his studies
      using PowerPoint slides to the audiences (about 5-10 min).

◆ Poster presentations

*All Posters will be displayed 9:00 - 17:00 (14 and 15), 9:00 - 11:00 (16), November 2011.
*Poster presenters are requested to submit her/his abstracts.
*Poster presentations will not be classified into any session topics