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eCTD Digital Handbook

December 2007

No more sifting through mountains of data! Gain easy, CD-access to a comprehensive collection of documents that offers electronic common technical document (eCTD) training and helps you establish and maintain an eCTD protocol, with the eCTD Digital Handbook from FDAnews. Order your copy today.

And, using the CD’s built-in search functionality, you’ll find what you need fast — including presentations, tutorials, documents and more that let you:

  • Understand the top 10 eCTD issues for successful submissions
  • Know the 11 key items you need to be aware of with esubmissions — a valuable checklist to run through each and every time you submit
  • Gain a thorough overview of the FDA’s eCTD guidance via an expert tutorial — includes all five modules of an eCTD, with:
    • Focus on ensuring your application is submitted successfully
    • Additional emphasis on facilitating the review process
  • Use Study Tagging Files properly — two tagging file problems discussed
    • Plus leaf titles and cross-dossier referencing
  • Put together a single core clinical study report that’s acceptable to all regulatory authorities of the ICH regions
  • Prepare the CTD for the Registration of Pharmaceuticals for Human Use for submission to the FDA using expert recommendations

Place your order today and you’ll have desktop access to 950 pages of the latest guidance — this CD also delivers details on submitting electronically for:

  • New drug applications
  • Drug master files
  • Abbreviated new drug applications
  • Biologics license applications
  • Periodic safety update reports
  • Investigational new drug applications
  • And other

For hands-on access to all tutorials, checklists, documents, and more place your order here.

Buy Now!
Order your copy of the eCTD Digital Handbook CD today for just $337 — 950 pages of tutorials, documents, checklists and more.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

Interested in Electronic Multi-user Access?
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable.

For more information please contact Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578