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Session 1 - Track 3: Document Preparation Across and Within Disciplines

Track 03

Day & Time:
October 16, 8:30AM - 10:00AM

Room Number:
Golden West


Session 1 - Track 3: Document Preparation Across and Within Disciplines

Hans van Bruggen, MSc
Senior Regulatory Affairs Scientist
eCTDconsultancy B.V., Netherlands

Within the pharmaceutical industry many disciplines contribute to the documentation to justify the quality, safety and efficacy of drugs. Not uncommon is the need to collaborate with CROs which might or might not have access to the same systems. Multiple individuals are involved in the authoring, review, QC and approval process. Processes can run in sequence or in parallel. Sometimes the process loops back to make corrections. All companies struggle with finding the balance between automated workflows, shared infrastructure, permissions, flexibility, transparency and above all; time constraints. This session will elaborate on case studies (lessons learned) and future directions.

Presentation(s) & Speaker(s):
Realize the Power of Document Collaboration and Ease the Pain of Regulatory Submissions
Dave Sheppard
Business Development Manager
PleaseTech Ltd, United Kingdom

Across the Divide: Key Messages Not To Miss!
Nancy P. Smerkanich, MSc
Educational Liaison/Regulatory Science Doctoral Student
University of Southern California, United States

The Power of Content Reuse within Clinical and Labeling Documentation
Shailesh Shah
Solutions Architect
ArborSys Group, United States

© 2014