eRegulatory Submissions - A Complete Lifecycle Tutorial

Wednesday June 10, 2009
11:00am EST / 4:00pm GMT

You are invited to join QUMAS and Extedo for webinar entitled 'eRegulatory Submissions - A Complete Lifecycle Tutorial'.

In an industry shaped by new regulations, global competition, and high market expectations, successful Life Sciences companies must bring new products to market faster than ever. Effectively managing the lifecycle of your submissions, and being prepared to handle any type of application that the regulators require, is critical to a firm's success. In this webinar Life Science companies will learn how to in expedite their marketing application process with better quality submissions, fewer iterations, and shorter review and approval cycles.

Featured Speakers:
Patricia Santos-Serrão, RAC, Manager Global Regulatory Solutions, QUMAS
Warren Perry, Director of eRegulatory Strategies, EXTEDO

This 60-minute webinar focuses on the following topics:

• Document management - keeping the needs of each functional area of R&D in mind (Clinical, Non-Clinical, CMC, RA)
• Effectively managing all of your publishing needs (legacy, paper, eCTD, CTD, medical device, and non-CTD regions)
• Benefits of integrating content management and submission management solutions
• How internal and external authors can collaborate and review documents more efficiently
• How to shorten your approval cycles
• Help your authors focus more on content and less on guidances with Intelligent Authoring Templates

You will have time to ask questions during the Q&A session at the end of the presentation. This webinar is aimed at Life Sciences executives working in Regulatory Affairs, Clinical, Nonclinical, and Quality departments.