How technology optimizes the publishing process for regulatory submissions

Duration: 60 minutes


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Why watch

Summary

Regulatory submissions are one of the most critical milestones for Life Sciences organizations and can consist of thousands of documents. Submitting on time and in full compliance with Regulatory Agencies' requirements remains a challenge for many companies.
Life Sciences organizations adopt cutting-edge technology, but the technology alone doesn't guarantee compliance & that timelines are met. Efficient processes combined with technology does. As software and related service solutions become “commodities” in the daily business, Life Sciences organisations require effective and secure solutions, that are compatible with their requirements and deliver results. As a solution provider, PharmaLex, in collaboration with DocShifter, helps to drive compliance while improving the efficiency of the publishing processes.  This is the start of the PharmaLex and DocShifter journey together, so listen to speakers from both organisations explain their exciting plans for the future.


 

Key Learnings

  •   Discover how to implement a proven document conversion and validation solution for pharmaceutical, biotech and medical device companies
  •   Learn about the software that automates, accelerates and simplifies the way to create submission-ready PDFs from original source documents; no matter which system these documents reside in
  •   Enrich your knowledge on how to streamline the eCTD publishing process, from the technological and workflow perspectives


     
speakers

A full hour of inspirational speaker(s)

Paul Ireland

VP Life Sciences, DocShifter, Belgium

Currently the VP of Life Sciences and Product Owner at DocShifter, Paul has over 20 years of experience in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Paul has practical industry and commercial experience in delivering content authoring & rendering, Regulatory Information Management, submission and report-level publishing, and electronic Document Management solutions.

 

Jennie May

Director, Regulatory Informatics and Operations, PharmaLex

Jennie has worked within the industry for over 20 years, with a focus on systems and processes to support the regulatory affairs business. ​At PharmaLex, Jennie is Director of Regulatory Informatics & Operations, focusing on Regulatory Systems Governance. ​She possesses a wealth of experience including RIM System implementation, business process review and improvement, regulatory intelligence and publishing.