The 7th PharmaDoc Users Conferenc

We appreciate your participation in the 7th PharmaDoc Users Conference.
Our deepest appreciation goes to our sponsors – Adobe Systems Inc., OpenText K.K. (Documentum), ShareSite Inc. (crossnote), Information Services International-Dentsu, Ltd. (Wingspan), Nomura Research Institute, Ltd. (Perma Document), and Veeva Japan K.K. (Veeva Vault).
At this PharmaDoc Users Conference, a keynote speech was given by Dr. Ryoichi Hiruma from Eisai Co., Ltd., a lecture was given by Mr.Hiroyuki Imanishi from Adobe Systems Inc., and an introduction of PharmaDoc Redact examples was given by Ms. Noriko Horigome from Sanofi K.K.
Additionally, lectures from overseas speakers were also given by Ms. Olga Alfieri from Eisai Inc., Mr. James Kelleher – CEO of generis, Ms. Lisa Ballanco from OpenText K.K., and Ms. Kathie Clark from Wingspan Technology, Inc.
We extend our sincere thanks to all of them for their lectures.
Next year’s 8th PharmaDoc Users Conference will be held at the same Sola City Conference Center on Friday, June 1, 2018.
We would like to plan for a users conference that will provide beneficial information for customers.
Scenes from the Users Conference have been uploaded to our HP. Please take a look.

Users Conference Venue

Keynote Speech:Current situation and Trend of Computerization for regulation toward to FY2020 Computerization Big Barn in Japan

Dr. Ryoichi Hiruma, Eisai Co., Ltd.

Users Conference

The Latest Update of Cloud Signing Service: Adobe Sign

Mr. Hiroyuki Imanishi, Adobe Systems Inc.

Users Conference

How Software Technology is Improving Global Regulatory Submission Document Deliverables, Quality, Reducing Costs and Accelerating Submission Timeline

(Speech via WebEx)(Simultaneous Interpretation)
Ms. Olga Alfieri, Director of Global Submissions Management, Eisai Inc.

Users Conference

Regulatory Information Management – A single system or a happy family?

(Speech via WebEx)(Simultaneous Interpretation)
Mr. James Kelleher,CEO generis

Users Conference

Adobe Systems Member Introduction

Users Conference

Planet Pharma Solutions Member Introduction

Users Conference

Buffet Party and Raffle

Users Conference
Users Conference

Exhibits by Sponsoring Companies

Adobe Systems Inc., OpenText K.K. (Documentum), ShareSite Inc. (crossnote), Information Services International-Dentsu, Ltd. (Wingspan), Nomura Research Institute, Ltd. (Perma Document), and Veeva Japan K.K. (Veeva Vault) all had their own booths set up for customer consultations.

Users Conference
Users Conference

PharmaDoc Server Products Introduction – Upcoming Development Functions and Cloud Support –

Mr. Masayuki Ueno, Ms. Mami Koike, and Mr. Takayuki Koike,
Planet Pharma Solutions, Inc.

Rendition server – PharmaDoc Generator

Functions of the latest version, PharmaDoc Generator 3.7, were introduced as the main focus.

Shared review system – PharmaDoc AnnotationX / review tool – PharmaDoc Reviewer

A demonstration of the shared review system, PharmaDoc AnnotationX, was provided.

Users Conference

Report publishing server – PharmaDoc Publisher / ClientPublisher

A demonstration of the Veeva Vault and PharmaDoc Publisher collaboration was provided

Mr. Kohei Suzuki, Veeva Japan K.K.

Users Conference

Transforming Regulatory Information Management (RIM)

(Simultaneous Interpretation)
Ms. Lisa Ballanco, US Life Science Senior System Engineer, OpenText K.K.

Users Conference

How Your Document Management System Can Help You Align with eCTD

(Video Speech )(Simultaneous Interpretation)
Ms.Kathie Clark, Vice President Product Management, Wingspan Technology, Inc.

Users Conference

Mr. Mitsuhiro Arase, Information Services International-Dentsu, Ltd.

Users Conference

Introduction and Demonstration of Upcoming Development Functions of PharmaDoc Client Products

eCTD support tool – PharmaDoc eCTDSupporters

Functions of the latest version as well as the next version, PharmaDoc eCTDSupporters 4.0, were introduced.

Mr. Satoshi Ohira, Planet Pharma Solutions, Inc.

Users Conference

Leaf file quality check tool – PharmaDoc LeafChecker

Functions of the PharmaDoc LeafChecker 4.4, which will be released in October 2017, were introduced.

Masking tool – PharmaDoc Redact

Functions of the latest version and the next version, PharmaDoc Redact 2.0, were introduced.

Ms. Juka Furuya, Planet Pharma Solutions, Inc.

Users Conference<

Case Study: Masking Tool PharmaDoc Redact at Sanofi

Ms. Noriko Horigome, Sanofi K.K.

A lecture was given regarding the condition when PharmaDoc Redact was introduced and benefits after the introduction, as well as upcoming company activities.

Users Conference

Current Status Report and Future Strategy

Number of pharmaceutical companies and CRO in the annual basic support agreement for PharmaDoc products (statistics by product)

The following topics were explained:

English support status of PharmaDoc products
Support system in Japan and global support system
Exhibit at the DIA RSIDM 2017 held in Washington D.C.
Path forward for quality assurance

Users Conference

Mr. Hidemichi Fukasawa,
Ms. Shiho Kakogawa, Ms. Mayuka Robins and Ms. Etsuyo Watanabe,

Planet Pharma Solutions, Inc.