Report on the 7th PharmaDoc Users Conference
Report on the 7th PharmaDoc Users Conference
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.
Keynote Speech:Current situation and Trend of Computerization for regulation toward to FY2020 Computerization Big Barn in Japan
Dr. Ryoichi Hiruma, Eisai Co., Ltd.
The Latest Update of Cloud Signing Service: Adobe Sign
Mr. Hiroyuki Imanishi, Adobe Systems Inc.
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.
Regulatory Information Management - A single system or a happy family?
(Speech via WebEx)(Simultaneous Interpretation)
Mr. James Kelleher,CEO generis
Adobe Systems Member Introduction
Planet Pharma Solutions Member Introduction
Buffet Party and Raffle
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.
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.
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.
Transforming Regulatory Information Management (RIM)
(Simultaneous Interpretation)
Ms. Lisa Ballanco, US Life Science Senior System Engineer, OpenText K.K.
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.
Mr. Mitsuhiro Arase, Information Services International-Dentsu, Ltd.
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.
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
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.
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
Mr. Hidemichi Fukasawa,
Ms. Shiho Kakogawa, Ms. Mayuka Robins and Ms. Etsuyo Watanabe,
Planet Pharma Solutions, Inc.