Navigating the FDA’s New Requirements for eCTD Submissions Mastering the Tools and Strategies: An

Venue: Radisson Hotel Boston

Location: Boston, Massachusetts, United States

Event Date/Time: Jun 09, 2009
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Description

In Navigating the FDA's New Requirements for eCTD Submissions, you will:

* Discover the top 12 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions and steps you should take to avoid these conditions in your source documents and eCTD compilation process
* Gain clarity on the acronyms and jargon of eCTD and electronic submissions
* Effectively budget for all scenarios of eCTD production — outsourcing, in-house publishing or a combination
* Develop project plans for eCTD submissions
* Understand why and how to start producing eCTD submissions at the IND phase
* Master the documentation requirements for electronic datasets for nonclinical and clinical studies and better communicate these requirements to colleagues early in the drug development cycle
* Understand how to impact the deliverables from outside suppliers — including contract writers, CROs and CMOs — to assure your company is receiving submission-ready documents and datasets
* Assure the output of your outsource vendor or in-house eCTD system is valid for FDA review
* Learn about the eCTD pilot — what it does, why you need it, how it works and how to make it work for you
* Learn about the FDA's Electronic Submissions Gateway (ESG) and how to prepare to submit your eCTDs electronically, including unique requirements the ESG imposes on your eCTD publishing process
* Create quality control checklists for documents and data to be included in your eCTD application
* Develop a cost-justification for outsourcing and know how to control your budget and avoid out-of- scope charges when outsourcing your eCTD
* Develop a business case for purchasing an eCTD system and electronic document management systems (eDMS) as part of your total solution for eCTD submissions
* Analyze cost and timelines for selection, implementation and validation of eCTD publishing systems and understand who the vendors are and their products' distinguishing characteristics
* Understand the interdependencies of submission life cycle and document management systems in combination with eCTD publishing systems and the importance of submission life cycle management
* Preview eCTD: The Next Generation — Regulated Product Submissions (RPS)
* Participate in breakout sessions where you'll develop an eCTD strategy for your company

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200 Stuart St.
Boston
Massachusetts
United States
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