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Home > DistinctHorizon > News > BioQuebec CFO Round Table: The Economic Impacts of an e-Submission Strategy
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BioQuebec CFO Round Table The Economic Impacts of an e-Submission Strategy  RSS feed
May 26th 2004 Managing Electronic Documents to Support Health Authority Requirements for Electronic Submission Helen Teichman, Senior Consultant/Specialist at DistinctHorizon Corporation will be giving a conference on the topic of "The Economic Impacts of an e-Submission Strategy" during BioQuebec's CFO Round Table. This event is co-sponsored by PriceWaterhouseCooper and Royal Bank of Canada. Date: Wednesday, May 26th, from 7h30 AM to 9h00 AM To attend please contact Ms. Michèle Corban at BioQuebec: (514) 733-8411 or services@bioquebec.com Managing Electronic Documents to Support Health Authority Requirements for Electronic Submission The value of your documents The size of an NDA submission can reach 500,000 to 1 million pages. But this huge collection of information reflects only a portion of all the scientific documentation that supports a product. For multiple reasons, Life Science companies must ensure the safe keeping of this documentation: support for ongoing scientific work, submission to regulatory authorities, audit by potential partners or to comply with international regulatory requirements. Maintaining all documentation as paper is time consuming, expensive, takes a lot of space and is not user friendly. Furthermore, health authorities are encouraging companies to submit electronic submissions. Major health authorities have adopted a harmonized standard for the submission of marketing applications (e.g. NDA). A rapid migration by regulatory agencies and industry to the new harmonized standards for the electronic Common Technical Document (e-CTD) is expected. Some agencies are already requesting that sponsors file submissions electronically. Electronic documents are easier to access, to modify, to update and to manage. For the past 10 years, electronic preparation of an IND or an NDA has been the preferred method of submission development of major pharmaceutical companies. Regardless of the format of submission (e.g. paper or electronic) production of any submission (e.g. IND) using electronic documents and assembly tools, enhances efficiency and reduces cycle time. Health authority regulations require that appropriate security is maintained – to access, make changes or re-use documents. Document management processes and technology are critical to maintain security and ensure robustness of the electronic records. Did you know: 75% of new NDA are electronic? Managing electronic documents in preparation for electronic submissions could speed up your daily operations as well as increase the ultimate value of your organization by demonstrating control over your vital records. About DistinctHorizon Corporation Information Management for Life Sciences The software MxDoc(tm) created by DistinctHorizon addresses companies’ Information Management needs and the 21 CFR Part 11 compliance issues. DistinctHorizon rapidly implements strategies, processes and procedures, related to electronically managing documents. About Helen Teichman Helen Teichman brings more then 20 years experience in regulatory affairs and document management to DistinctHorizon’s clients. Helen Teichman does independent process consulting specializing in electronic document management, eCTD readiness, and submission preparation.
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