is being presented by Gina Ross, , Director, Quality Document Systems Management, with Beckloff Associates and airs on Tuesday, Novemeber 30th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
A sound regulatory strategy, combined with proactive lifecycle management of electronic submissions, can speed the regulatory review and approval process and reduce the regulatory burden, expand marketing applications to additional jurisdictions and drive successful regulatory approval outcomes.
To be truly successful at integrating regulatory strategy and eCTD lifecycle management, sponsors need to evaluate their existing document authoring and submission compilation activities and determine what, if any, modifications are necessary to accommodate the eCTD specifications. Document authors need to understand not only the CTD guidelines, but also have a working knowledge of the eCTD guidelines and application of the lifecycle operation attributes. Regulatory affairs and regulatory operations (i.e. publishers) need to have an in-depth knowledge of the CTD and eCTD guidelines, as well as the electronic requirements of multiple global regulatory agencies.
This audio conference is designed to help organizations and individuals understand the relationship between regulatory strategy and the eCTD lifecycle management, and to effectively develop systems, processes and procedures to support the chosen strategies and facilitate the future lifecycle management of applications.
