Regulatory Submissions, Information, and Document Management Forum 2023 (DIA RSIDM)

13 Feb 2023 7:30 AM –15 Feb 2023 5:30 PM

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road,
North Bethesda, MD 20852
USA

Speakers 

Paul Ireland (VP Life Sciences – DocShifter) on 

How to Fully Automate the Creation of Your Regulatory and other Company Reports (Session 9 Track 3: Using Automation to Replace Manual Documentation Processing, Realize Resource Efficiencies, and Gain Valuable Insights Into Your Data)

Brief Summary: 

This presentation explains how to leverage existing technology to fully automate the creation of regulatory and other company reports. It will discuss how existing processes that require either multiple manual tools or complex publishing solutions can be replaced with a fully automated process. Once the collection of documents has been defined, wherever it is stored, cover pages, tables of contents, pagination, content merging and splitting can all be applied without any manual steps. The resulting PDF(s) can be generated in full compliance with any required technical specifications to minimize additional submission content preparation steps. Practical examples will be used to demonstrate the benefits this automation can provide.

Learning Objectives: 

After following this presentation, the attendees will be able to: 

1. Understand the limitations their current report generation processes create.
2. See that it is possible to fully automate the report generation process regardless of where the content resides.
3. Walk away with practical, easy to implement suggestions for improvement across all groups involved in the creation of reports from regulatory and across the enterprise.

Geert Van Peteghem on

How Automated Checking & Fixing of Word & PDF Content Accelerates Achieving Submission Compliance (Session 8 Track 4: Submission Quality)

BRIEF SUMMARY

This presentation explains how automating the identification of issues in your Word and PDF content earlier in your content preparation processes can help streamline your submission processes and reduce your risk of non-compliance. Through practical examples, it will explain that it is possible to fully-automatically look for and fix Word content issues prior to conversion into PDF format. It will then demonstrate that performing PDF compliance checks without human intervention, resolving any issues systematically and reporting any remaining items of concern is achievable. It will outline what types of checks can be performed and the potential time savings and overall benefits such automations can deliver.

Learning Objectives: 

After following this presentation, the attendees will be able to: 

1. Assess how their current process of preparing compliant output for regulatory submissions stacks up with their peers in the industry.
2. Understand how creating fully technically compliant output earlier in the submission process will positively impact their submission preparation.
3. Walk away with practical, easy to implement suggestions for improvement across all groups involved in submission content preparation.