Preparing for New Electronic Submission Deadlines Mastering eCTD Tools and Strategies

$1,797.00

Beginning October 1, the FDA gained the regulatory authority to require electronic submissions for INDs, NDAs, BLAs, ANDAs, DMFs and all CDRH pre- and post-approval submissions.

If you understand the FDA’s new requirements, you can satisfy any regulator worldwide. This two-day interactive workshop will bring you fully up to speed.

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 for Preparing for New Electronic Submission Deadlines on Dec. 6-7, 2012, in Raleigh, NC.

Space Is Limited — Register Today!

Attend Preparing for New Electronic Submission Deadlines 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

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
  • Software
  • Sample submissions for eCTD and CDRH Electronic Copy
  • White papers
  • And much, much more!

Read Rave Reviews from Past Attendees

  • 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.

To reserve your room, call the hotel at the number below. Be sure to tell the hotel you’re with the FDAnews workshop to qualify for the reduced rate. Only reservations made by the reservation cutoff date are offered the special rates, and space is limited. Hotels may run out of discounted rates before the reservation cutoff date. The discounted rate is also available two nights before and after the event based on availability. Hotel may require first night’s room deposit with tax. Room cancellations within 72 hours of the date of arrival or “no-shows” will be charged for the first night’s room with tax.

Dec. 6-7, 2012
Marriott Raleigh Crabtree Valley
4500 Marriott Dr.
Raleigh, NC 27612
Toll Free: (800) 228-9290
+1 (919) 781-7000
www.raleighmarriott.com
Room rate: $144.00 plus 12.75 percent tax
Reservation cut-off date: Nov. 15, 2012

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

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. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

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

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

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 of 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.

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, HoffmannLa Roche k

“With over twenty years in the industry, Antoinette brings a wealth of experience and knowledge in the electronic submissions and document management areas. In the past 10 years, I have drawn on Antoinette's expertise for large and small electronic submission and document management projects. Each time, she has delivered above my expectations. She is respected in the pharmaceutical industry as a subject matter expert for electronic submissions to health authorities. It is her experience, knowledge and work ethic that has earned her that respect."
Jim Lengner, Director, Operations and Regulatory Information Management, Regulatory Affairs, Sanofi Pasteur

"Ms. Azevedo is a longstanding, industry-recognized subject matter expert in regulatory submissions to the FDA and international regulatory agencies. Ms. Azevedo is unique in the regulatory submissions industry in that she provides her clients with strategies for regulatory submissions. This clearly differentiates her from many other providers. Bottom line, I take my business to e‑SubmissionsSolutions.com for regulatory submissions solutions. And when it comes to paperless, eCTD filings, Ms. Azevedo is the “go to” authority. Just ask what clients retain her business. If top global biotech and pharmaceutical firms can rely on Antoinette, we all can. I do."
Steven Gerken, Ph.D., MBA, President, Avitacor LLC

"Antoinette is a great resource for eCTD and has been very valuable to our organization. Her feedback is very helpful and her technical knowledge is outstanding!"
Dana Hettinger, Manager, Regulatory Document Operations, Takeda Global Research & Development Center

"This was an unbelievably successful workshop and I am so thankful I attended it. Antoinette was a wonderful speaker with so much expertise."
Carly Zehner, Electronic Submission Specialist, APP

“Lots of information delivered in a logical and understandable manner.’
Katherine Ulman, Global Regulatory Expert, Dow Corning