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.
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.
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.