|By PR Newswire||
|November 13, 2012 08:43 AM EST||
FALLS CHURCH, Va., Nov. 13, 2012 /PRNewswire-iReach/ -- Preparing for the New Electronic Submission Mandates:
Mastering the Tools and Strategies
**Presented by FDAnews and e-SubmissionsSolutions.com**
Dec. 6-7, 2012 – Raleigh, NC
Electronic submissions are going global, and the FDA is leading the way.
If you understand the FDA's requirements, you can satisfy any regulator worldwide. This two-day interactive workshop will bring you fully up to speed.
President Obama signed the FDA Innovation and Safety Act that, beginning October 1, 2012, mandates electronic submissions for INDs, NDAs, BLAs, ANDAs, DMFs, and all CDRH pre- and postapproval submissions. Every day regulatory authorities across the globe are turning to electronic submissions as their new preferred format ... and the FDA is leading the way.
If you don't yet have your electronic submission process perfected, there's no time to lose.
Many drug, biologic and device companies can already measure the difference in dollars — through increased first-time acceptance rates, shorter FDA review times, and yes, speed to market.
Your colleagues and competitors have already found the key.
You can, too, in the hands-on workshop that gives you the eCTD tools and tactics to satisfy any regulator worldwide.
Don't delay. Register now and mark your calendar for Preparing for the New Electronic Submission Mandate on December 6-7, 2012, in Raleigh, NC.
Attend Preparing for the New Electronic Submission Mandate and you will:
- Discover the top 10 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
- Compare the similarities and differences between the eCTD format and CDRH's Electronic Copy format.
- Target skill requirements for MS Office and Adobe Acrobat that apply across all electronic submission standards.
- 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 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 system (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
- Participate in breakout sessions where you'll develop an eCTD strategy for your company
Your Workshop Instructor
This workshop's expert instructor, Antoinette Azevedo, founded eâ€'SubmissionsSolutions.com to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions.
She was director of West Coast Operations for Liquent from 1997 to 2000. She was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients both large and small in North America and Western Europe.
You Get Complete Presentation Slides & CD of Invaluable Documents
Plus, you'll walk away from this interactive workshop with presentation slides and a valuable CD you can put to use immediately that includes:
- QC checklists for MS Word files and PDF files
- MS Project plan for eCTD and study reports
- Document inventory for eCTD RFI/RFP
- Sample eCTD RFP and requirements matrix
- ICH and FDA and global health authority guidances
- List of EDMS vendors, including a matrix that cross-references
integration between eCTD and EDMS systems
- MS Word template example for creating submission-ready PDF files
- Sample submissions for eCTD and CDRH Electronic Copy
- White papers
- And much, much more!
Preparing for the New Electronic Submission Mandates:
Mastering the Tools and Strategies
**Presented by FDAnews and e-SubmissionsSolutions.com**
Dec. 6-7, 2012 – Raleigh, NC
TUITION: $1,797 per attendee
4 Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
Mail to: FDAnews
300 N Washington St
Falls Church VA USA 22046-3431
SOURCE New Electronic Submission Mandate
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