Preparing for the New eCTD Mandates

Conference

Preparing for the New eCTD Mandates:
Mastering the Tools and Strategies

Bethesda, MD • June 10-11, 2014

Preparing for the New eCTD Mandates
Mastering the Tools and Strategies

 
Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions, and the steps you should take to avoid these conditions in your source documents and eCTD compilation process.

This interactive workshop will teach you tactics and give you tools to succeed far beyond your expectations in the brave new world of eCTD.

Preparing for the New eCTD Mandates
Mastering the Tools and Strategies

An Interactive Workshop presented by
FDAnews and e-SubmissionsSolutions.com

Many drug, biologic and device companies utilizing eCTD can already measure a striking difference … through increased first time acceptance rates … shorter FDA review times … speed to market … and, yes, increased revenue.

Indeed, the mandated move to eCDT is beginning to reveal its positive up side.

There's no doubt change is difficult. No one likes devoting endless hours to learning new processes while they give up comfortable old legacy systems and formats.

But there's a new wave of confidence within those companies that have taken the leap to eCTD  … confidence in improved efficiencies … time and cost savings … increased speed in submission through use of ESG … easier access to eCTD submissions for your own internal due diligence and strategic research … the attractiveness of advanced technology to potential investors … the list goes on and on.

And now, you can to can jumpstart (or shore up!) your company's own transition to eCTD by attending Preparing for the New eCTD Mandates: Mastering the Tools and Strategies on June 10-11, 2014.

You'll be able to take advantage of the vast experience of workshop leader Antoinette Azevedo, a leading software developer and expert in the use of technology to manage regulatory documents and publish electronic submissions. She'll provide real-world insights from implementing her system and producing eCTD submissions for global life sciences companies.

During this interactive workshop, you'll gain amazing insights and knowledge — and have your toughest questions answered. You will:

  • Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions, and the steps you should take to avoid these conditions in your source documents and eCTD compilation process
  • Participate in breakout sessions where you'll develop an eCTD strategy for your company
  • 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.
  • Master the documentation requirements for electronic datasets for nonclinical and clinical studies and learn to 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
  • Learn about cloud-based solutions for eCTD and EDMS that speed the time of implementation and reduce the cost of capital and validation services.
     

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 plans for eCTD and study reports
  • Sample eCTD RFI/RFP and requirements matrix
  • ICH, FDA and global health authority guidances and specifications
  • List of eCTD and EDMS vendors
  • MS Word template example for creating submission-ready PDF files
  • Software
  • Sample submissions for eCTD and CDRH Electronic Copy
  • White papers
  • And much, much more!


So, clear your calendar for Preparing for the New eCTD Mandates on June 10-11, 2014. It's your opportunity for "total immersion" in the extraordinary benefits for your company in moving sooner, rather than later, to FDA-mandated eCTD submissions.

Register today.