Events

2019.05.31PharmaDoc Users Conference

Report on the 9th PharmaDoc Users Conference

2018.06.01PharmaDoc Users Conference

Report on the 8th PharmaDoc Users Conference

2017.05.26PharmaDoc Users Conference

Report on the 7th PharmaDoc Users Conference

2017.02.08dia-exhibit

Exhibited at the Forum hosted by DIA.

2016.03.09exhibit

PharmaDoc products were exhibited at the 5th Symposium hosted by the eCTD Research Group.

2015.09.17lecture

Lectured "Introduction to PDF II: Basic Knowledge of Acrobat and PDF (2)" at the eCTD Personnel Training Course hosted by the eCTD Study Group.

2014.11.26exhibit

PharmaDoc products were exhibited at the 4th Symposium hosted by the eCTD Study Group.

2014.11.26lecture

Gave a presentation entitled "Technical Explanation of PDF Shared Review Mechanisms" at the 4th Symposium organized by the eCTD Study Group.

2014.10.23lecture

Lectured "Introduction to PDF II: Basic Knowledge about Acrobat and PDF (2)" at the eCTD Personnel Training Course hosted by the eCTD Study Group.

2013.09.26lecture

Gave a lecture on Introduction to PDF "Basic Knowledge about Acrobat and PDF" at the eCTD Personnel Training Course hosted by the eCTD Study Group.

2013.07.09exhibit

PharmaDoc products were exhibited at the 2nd Symposium hosted by eCTD Study Group.

2012.10.11exhibit

Exhibited at the eCTD Research Group's 2nd Educational Seminar (Move Machiya 4F Exhibition Hall)

2012.05.09 - 2012.05.10exhibit

Exhibited at the 10th MIST Symposium (10th Anniversary Conference)

2012.01.25exhibit

Exhibited at the exhibition and information session on eCTD (Tower Hall Funabori) hosted by the eCTD Study Group.

2011.12.07lecture

Lectured at the seminar "eCTD Application - eCTD Application has become so much more accessible -".

2011.11.16exhibit

We exhibited and gave a presentation of our products at the 2011 MIST Jam (2nd MIST Corporate Exhibition and Consultation) hosted by NPO Publicware Promotion Organization. (Presentation time: 15:30-16:00)

2010.07.30lecture

Presented at the Technical Information Association of Japan seminar on Quality Assurance and Process Improvement of Leaf Files for Successful eCTD Applications

2010.07.28exhibit

Exhibited at the 7th MIST Subcommittee Symposium "Current Status and Future Prospects of Security and the Latest Technologies" and gave a presentation on our products

2010.03.15exhibit

Exhibited at the MIST subcommittee corporate member company joint exhibition and consultation

2009.12.01lecture

eCTD and PDF" What are the PDF fundamentals required by pharmaceutical customers?
Presentation at Adobe Industry Seminar for the Pharmaceutical Industry (PDF file)

2009.07.10exhibit

Exhibited at the 5th MIST Subcommittee Symposium, "Measures Toward Full-Scale Implementation of Electronic Approval Applications and Examinations

2009.07.09lecture

How to create good quality leaf files quickly / Lecture at the 7th eCTD Study Group

2009.06.09lecture

Lecture on leaf file preparation for eCTD compliance at Information Technology Organization of Japan Pharmaceutical Seminar

2009.04.16exhibit

Exhibited at CAC 10th eCTD Seminar

2008.07.02 - 2008.07.04exhibit

Exhibited at the 21st INTERPHEX JAPAN

2008.03.06exhibit

Exhibited at the 3rd MIST Subcommittee Symposium "IT in Drug Development: Electronic Clinical Trials and eCTD

2007.07.20lecture

Problems of PDF in eCTD and how to deal with them / Lecture at the Pharmaceutical Information Systems Study Group

2007.05.24lecture

Quality assurance of leaf files in eCTD / Lecture at the Japan QA Research Association Special Project

2007.05.23lecture

Lecture on how Acrobat font display works / Lecture at a user group for clinical management for a pharmaceutical company

2006.08.04lecture

Lecture on PDF/A, the standard for long-term preservation of documents / Lecture at a user group for safety information management for a pharmaceutical company

2013.02.22Books

Our company was responsible for writing Section 7, “Creating a System Test Plan and Conducting System Tests,” in Chapter 2 of the Technical Information Association's “Case Studies of Practical Measures for the Appropriate Management of Computerized Systems and Document Creation in the Development and Manufacturing of Pharmaceuticals, Medical Devices, and In Vitro Diagnostic Medical Devices” (published at the end of March).

2011.11.07Books

We have published the book, "eCTD Application - eCTD Application has become so much more accessible now.

＜Author＞
Mr. Ryoichi Hiruma, Eisai Co., Ltd.
Hidemichi Fukazawa, Planet Pharma Solutions, Inc.

(Our company was responsible for writing the technical knowledge section of Part 2 of the PDF.)

The series of six articles titled "Points to keep in mind when preparing leaf files for a successful eCTD application" began in the December 2010 issue of PHARM STAGE monthly magazine.

• Part1　About Adobe Acrobat and PDF (December 2010)
• Part2　Basic knowledge about leaf files (1) (January 2011)

• Part3　Basic knowledge about leaf files (2) (February 2011)

• Part4　Differences between PDFMaker and Rendition engines (March 2011)
• Part5　Quality of leaf files in eCTD (April 2011)
• Part6　The Latest Status of eCTD (May 2011) (Written by Mr. Ryoichi Hiruma, Eisai Co., Ltd.)