Navigating the FDA's New Requirements for eCTD SubmissionsMastering the Tools and Strategies: An Interactive Workshop

$1,797.00

Navigating the FDA's New Requirements for eCTD Submissions
Mastering the Tools and Strategies: An Interactive Workshop

Hilton San Diego Resort • San Diego, CA • Oct. 1-2, 2007

Requiring eCTDs for CDER electronic submissions is only the beginning. Are you and your staff prepared?

The FDA is moving quickly toward establishing an all-electronic system environment. So quickly that it even held a meeting on Part 15, taking the place of any pre-rulemaking activities and giving the FDA the authority to go straight to a final rule.

Join us for two days of intensive training to educate drug, device and biologics personnel with the knowledge and expertise needed to electronically file eCTDs with the FDA. Through a series of interactive exercises, case studies and small group discussions, you'll leave knowing how to produce an eCTD, how to manage an eCTD and where the FDA is headed next.

Space is Limited — Register Today!


Click here to view the brochure.


Click here to view the agenda.

In Navigating the FDA's New Requirements for eCTD Submissions, you will:

  • Discover the top 12 reasons sponsors receive a refuse-to-file (RTF) from the FDA on their eCTD submissions
  • Gain clarity on the acronyms and jargon of eCTD and electronic submissions
  • Effectively budget and 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 stability, nonclinical and clinical, and better communicate these requirements to colleagues early in the drug development cycle
  • Assure the output of your in-house 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
  • Create quality control checklists for documents and data to be included in your eCTD application
  • Develop a cost-justification for outsourcing or purchasing an eCTD system, and know how to control your budget and avoid out of scope charges when outsourcing your eCTD
  • 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)
"Antoinette is an industry leader in electronic submissions technologies. Drawing from her multiple successes, she provides her clients a path toward successful implementation of technologies like the eCTD. She knows it's about the people, process and technology."
John Oidtman
Vice President, Worldwide Regulatory Operations, Pfizer

Click here to read more comments from your colleagues.

Your valuable course materials book is packed with tools you can put to use right away, including:
  • White Paper — Requirements for CROs on producing CRFs and CRTs
  • White Paper — Best practices in the use of MS Word
  • White Paper — ICH requirements for publication references
  • MS Project plan for eCTD
  • Document inventory for eCTD RFI/RFP
  • Sample eCTD RFP and requirements matrix
  • List of outsource services vendors
  • List of SPL/PIM software solutions
  • List of SPL/PIM conversion services
  • List of CDISC product and service providers
  • List of MS Word template vendors for eCTD
  • QC checklist for MS Word files
  • QC checklist for PDF files
  • ICH and FDA guidances
  • List of eCTD publishing systems vendors with product datasheets
  • List of EDMS vendors, including matrix that cross-references integration between eCTD and EDMS systems
  • Background information on RPS

Here's what your colleagues say
"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 ten 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 long standing, 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 eSubmissions Solutions 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

"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

"Microbia has been working with Antoinette since our very first IND submission in 2004 and she got us to a point where we could run independently. Now that we are embarking on eCTD, it is clear that Antoinette is at the forefront of her field. She is very knowledgeable in eCTD and has given us practical advice that we trust."
Christine Pierce
Manager of Regulatory Affairs
Microbia

"Antoinette is a valuable resource and knowledge base that I have repeatedly relied upon to reach critical electronic submission goals. Her considerable experience, involvement in evolving technologies, and extensive contacts throughout the industry provide trusted solutions to new and developing challenges in the eCTD and EDMS worlds."
Liam Curran
Associate Director, Regulatory Operations
Gilead Sciences

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. Her clients range from large, international pharmaceutical companies to small, virtual biotechnology companies.

Antoinette 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 in North American and Western Europe. Her entire career has been devoted to document management and electronic publishing through several generations of technologies and architectures, in various industries. She dedicated her focus to life sciences beginning in 1994. She is experienced with a number of document management systems, publishing systems and toolsets, and a wide array of options for successfully producing electronic submissions. Her experience ranges from developing strategies for document management and electronic publishing to implementation of fully validated systems, and production of paper and electronic submissions accepted for review by regulatory authorities worldwide.

Antoinette is the author of <SGML> Competitors & Markets, Products & Applications, 1994-1998. She has lectured internationally for RAPS, DIA, at vendor user conferences, and for local regulatory affairs professional groups.

Send Your Team for Maximum Benefit
Get your team up to speed in just two days!

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.

Oct. 1-2, 2007 San Diego, CA
Hilton San Diego Resort
1775 East Mission Bay Drive
San Diego, CA 92109
Toll free (800) 445-8667
1 (619) 276-4010
www.sandiegohilton.com

Lodging:
Hilton San Diego Resort
1775 East Mission Bay Drive
San Diego, CA 92109
Toll Free (800) 445-8667
1 (619) 276-4010
www.sandiegohilton.com
Room rate: $189.00 single or double (plus 10.55% tax, plus 7.75% sales tax)
Hotel reservation cutoff date: Sept. 12, 2007

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

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