Presenter:
Helen Teichman, President, Chestnut Solutions Inc.
Helen Teichman is President of Chestnut Solutions Inc., a consulting practice specializing in helping companies prepare for electronic submissions. Helen worked as a regulatory affairs professional for over 20 years. She spent many years with the Johnson & Johnson family of companies at which she held senior management positions in Canada, the US and Europe, and has experience in pharmaceuticals, biologics and Medical Devices.
After leaving Johnson & Johnson, Helen joined a Washington-based management consulting firm as Vice President, Pharmaceutical. There she specialized in strategic and process-related consulting for the pharmaceutical industry. In 2003, Helen formed Chestnut Solutions and since then has specialized in helping companies develop strategies and tactics to support electronic submissions.
Pharmaceutical and biotech companies have been submitting electronic marketing applications to agencies for a number of years. Recently, the EU has mandated eCTD for centralized procedures and many European countries no longer accept paper submissions for national procedures. The FDA has mandated eCTD as the only acceptable format for electronic submissions. Canada recently expanded the types of submissions that can be filed electronically. Several other agencies in Europe (e.g. Switzerland) are moving to eCTD, and this month, new eVeterinary guidelines were announced. So the trend is here - electronic submission of regulatory information. Much has been learned over the months and years about managing electronic documents, preparing submission ready documents and guiding document authors and reviewers into electronic environments.
It seems like it would be an easy process change since everyone uses WORD, PDF and computers. But, it means implementation of technology as well as process change. New standards have to be developed and implemented in order to meet the requirements of electronic submissions. New ways of working need to be adopted.
Attend this webinar for a review of:
- lessons learned in the pharmaceutical industry as well information on best practices leading to successful implementation of electronic document management and preparation of submission ready documents, with a focus on process and standards.
- the types of SOPS that are required to support electronic authoring and document management (e.g. requirements for contractors' documents).
- the requirements for templates, bookmarks, hyperlinks and document standards within a submission-ready PDF
Once the process steps are known, it is important for a company to perform a gap analysis to evaluate how well they are working in an electronic environment:
-- do they manage documents electronically?
-- do they use templates?
-- do they maintain the approved documents in paper or electronic or both?
Following the webinar you will understand:
- Top 5 challenges in moving to electronic submissions
- Managing documents electronically
- Submission-ready standards
- What templates can do
- What should be included in a Gap Analysis
- Selecting technology that works for you
Who should attend this Webinar?
Regulatory, Clinical, IT