Preparing for the New Global Requirements for eCTD and Regulated Product SubmissionsMastering the Tools and Strategies
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.
Paper submissions are losing traction and that's no secret. Every day regulatory authorities across the globe are turning to electronic submissions as their new preferred format ... and the FDA is leading the way.
With RPS (Regulated Product Submission) poised to build on the eCTD standard, 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, plus prepare for RPS.
Don’t delay. Register now and mark your calendar for Preparing for the New Global Requirements for eCTD and Regulated Product Submissions on May 24-25, 2010 in Boston, MA.
Attend Preparing for the New Global Requirements for eCTD and Regulated Product Submissions and 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