ISI Announces eCTD Readiness Workshop Series
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WHIPPANY, N.J., May 1:Image Solutions Inc., (ISI), a leader in providing software and service solutions to support the drug development lifecycle, announced today that it will continue its series of workshops in the United States on the electronic Common Technical Document (eCTD), offering best practices oriented training in hotbed areas on the West Coast and in the Northeast.
Designed specifically for Life Science professionals, ISI's eCTD Readiness Workshop educates participants on the basic structure and details of assembling the Common Technical Document (CTD) and eCTD. The workshop begins with a brief history of the ICH and the global regulatory context for eCTDs. It continues with details on document granularity, application and document lifecycles, study tagging files, hyperlinking document content, PDF requirements, electronic submission logistics and more. The sessions are intended to stimulate discussions on the planning and milestones of submitting a compliant eCTD.
Throughout the workshop, discussions will focus on how to overcome the challenges of the eCTD by understanding technical and process-related pitfalls, transition pain-points and quality control recommendations. With more than 350 successful eCTD submissions to its name, ISI remains committed to passing on field-tested experience and lessons learned to workshop participants. The topics in this workshop are presented by expert trainers who are grounded in years of successful submissions.
Workshop Learning Objectives.
Participants will have had the opportunity to:
o Review the global regulatory context for the eCTD.
o Gain a thorough understanding of the eCTD concept and structure.
o Become familiar with the underlying XML technology used in the eCTD.
o Understand how the eCTD organizes special file types, including Study
o Tagging Files, Datasets, labeling including both SPL and PIM, and more.
o Learn about approaches to the lifecycle management concepts in the
eCTD.
o Obtain knowledge on regulatory agency requirements for an eCTD,
including how to prepare for a required pilot submission.
o Understand hyperlinking strategies within an eCTD.
o Exchange ideas with other participants.
o Discuss the steps necessary to move toward eCTDReadiness and eventual
eCTD submission.
Participants receive a 300-page eCTD Readiness Workbook with critical industry information and ISI's lessons learned on eCTD preparation and how to move towards eCTD readiness efficiently. Workshops held at ISI headquarters office in Whippany, NJ will be held in newly constructed classrooms with state of the art computers and training technology.
Dates and Locations:
o Waltham, MA. June 4 (one-day workshop)
o San Diego, CA. May 23-24, 2007
o San Diego, CA. July 24-25, 2007
o San Francisco, CA. July 26-27, 2007
o Whippany, NJ. June 6-7, 2007
Individuals interested in attending the workshop can register on our web site at imagesolutions.com/eCTDReadinessWorkshop, or by contacting Keith Ward at ISI, keith.ward@imagesolutions.com, or calling 866-827-5827.
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered more than 600 electronic submissions and 350 eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. For more information, visit the company website at www.imagesolutions.com.
Source: Image Solutions Inc.
CONTACT: Keith W. Ward, Associate Director, Global Marketing, Image Solutions Inc., +1-973-560-0404 x324, fax, +1-973-560-0241
Web site: www.imagesolutions.com/ http://imagesolutions.com/eCTDReadinessWorkshop
