Preparing for the New Global Requirements for eCTD and Regulated Product SubmissionsMastering the Tools and Strategies

$1,797.00
If you fully understand the FDA's eCTD and RPS requirements, you can satisfy any regulator worldwide. This workshop will bring you 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 found the key.

You can, too, in this 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.



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Space Is Limited — Register Today!

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

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
  • List of SPL/PIM software solutions
  • MS Project plan for eCTD and study reports
  • Document inventory for eCTD RFI/RFP
  • Sample eCTD RFP and requirements matrix
  • ICH and FDA guidances
  • List of eDMS vendors, including a matrix that cross-references integration between eCTD
    and eDMS systems
  • And much, much more!

Here's what previous attendees have to say:

"Antoinette is extremely knowledgeable regarding needs across the industry."
Kristina Oaks, Report Coordination Supervisor, SNBL USA

"Antoinette's expertise in the fields of document management and electronic publishing is unquestionable. She understands all of the potential hurdles — not just current FDA/ICH standards, but also hardware issues, software issues, IT support, need for document control and even the struggles with internal resistance to standardization and change. This is truly her niche, and she is able to customize the approach and the solutions to fit a wide variety of companies, projects and needs within the pharma/biotech industries."
Kathleen Gibbon, RAC Senior Director, Regulatory Affairs, Avera Pharmaceuticals

"Antoinette knows the topic well, was very helpful and open to questions and suggestions. She led the discussion well and provided a wealth of information. The workshop materials were very comprehensive with good handouts, takeaways and valuable tools."
Peter Prince, Director, Regulatory Submissions, Hoffmann–La Roche

  • Regulatory affairs
  • IT personnel who support regulatory staff
  • Dossier managers
  • Documentation/report services staff
  • R&D staff
  • Clinical affairs personnel
  • Medical writers
  • Compliance officers
  • Consultants/service providers/regulatory operations managers
  • Data management and statistics personnel
  • Engineering and design control teams
  • Executive management
  • Managers
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Strategic planning and business development staff
This workshop's expert instructor, Antoinette Azevedo, founded e-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.

May 13–14, 2010
Marriott Raleigh Crabtree Valley
4500 Marriott Drive
Raleigh, NC 27612
Telephone: +1 (919) 781-7000
Toll Free: (800) 228-9290
www.raleighmarriott.com
Room rate: $149.00 (plus 12.75% tax)
Reservation cutoff date: April 21, 2010

Register Early — Space is Limited

Hurry — register early because space is limited! Your tuition of $1,797 per attendee includes the two-day workshop, all conference materials, continental breakfast and lunch each day.

 

Send Your Team for Maximum Benefit
Get your team up to speed!

Significant tuition discounts are available for teams of three or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount.

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

 

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.