is being presented by Dr. Susan Sisk, Principal, with SFP Consulting and airs on Wednesday, October 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.
In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.
Showing posts with label electronic submissions. Show all posts
Showing posts with label electronic submissions. Show all posts
Tuesday, September 6, 2011
Thursday, October 7, 2010
Improving the Efficiency of Regulatory e-Submissions
is being presented by Donald Palmer, Associate Director, Regulatory Systems, with MedImmune and airs on Tuesday, November 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com
As more companies work closely with partners, outsource partners, or CROs, the need to standardize processes and requirements for electronic submissions is becoming more pronounced. In addition, there is a need for these interactions to be efficient, from publishing processes and systems to document management, to the authoring process.
This audio conference presentation looks at the current types of processes and technology needed for electronic regulatory submissions, for companies both small and large. It also considers possible changes to these processes and technology, as a company grows and/or seeks to gain greater efficiencies. The speaker also looks at where tools might be developed and/or integrated for further efficiencies.
As more companies work closely with partners, outsource partners, or CROs, the need to standardize processes and requirements for electronic submissions is becoming more pronounced. In addition, there is a need for these interactions to be efficient, from publishing processes and systems to document management, to the authoring process.
This audio conference presentation looks at the current types of processes and technology needed for electronic regulatory submissions, for companies both small and large. It also considers possible changes to these processes and technology, as a company grows and/or seeks to gain greater efficiencies. The speaker also looks at where tools might be developed and/or integrated for further efficiencies.
Monday, September 21, 2009
Managing the Shift to Electronic Submissions
The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.
The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD requires sponsor organizations to rethink their business and those with whom they do business.
Managing the Shift to Electronic Submissions was presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates a Cardinal Health and aired on 2008-04-17. For more information, or to download this audio conference please visit our site at www.fxconferences.com
The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD requires sponsor organizations to rethink their business and those with whom they do business.
Managing the Shift to Electronic Submissions was presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates a Cardinal Health and aired on 2008-04-17. For more information, or to download this audio conference please visit our site at www.fxconferences.com
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