eCTD Requirements Where Are You on The Curve?

Held Feb. 14, 2013

In Jan. 2013, the FDA released a revision to their eCTD guidance and provided some feedback as to what’s working and what’s not.

Unfortunately, the FDA guidance doesn’t address the business and technical skills users must have. And to compound matters, the FDA continues to tighten its validation criteria for eCTD submissions.

To help you survive, e‑SubmissionsSolutions’ expert Antoinette Azevedo discusses the necessary skills beyond what’s listed in the guidance with her proven eCTD Roadmap.

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If you find yourself asking any of these questions — you’re not alone.

  • How do I validate compliance of MS Word and Adobe Acrobat with eCTD submissions?
  • How should I name files so they can be used directly by an eCTD compilation tool?
  • How do I organize my project plan to track all the files coming from across the company?
  • How do I tie the project plan to the submission plan in order to have a checklist to verify all the content intended to be submitted is, in fact, correctly located in a submission sequence, with the correct metadata required by the eCTD format?
  • How do I perform lifecycle management of the content across multiple submission sequences?
  • How do I implement digital certificates, secure email with FDA and create an Electronic Submission Gateway account?

Avoid the traps and costly quality assurance mistakes that plague users and companies. Don’t fall victim to thinking that just because you have your in-house eDMS it will be easy to outsource your submission publishing project. All the content needs to be correctly exported so that you don’t lose chain of custody and audit trails.

Your colleagues and competitors have already found the key. Don’t delay. Order your audio CD/Transcript of the eCTD Requirements: Where Are You on The Curve? webinar.

Antoinette Azevedo has received rave reviews from industry professionals for her expertise and teaching style:

"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.”
Kathleen Gibbon, Senior Director, Regulatory Affairs, Avera Pharmaceuticals

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Order eCTD Requirements: Where Are You on The Curve? and you will:

  • Understand why and how to start producing eCTD submissions at the IND phase
  • Discover the top 10 reasons FDA refuses to review eCTD submissions and steps you should take to avoid these conditions in your source documents and eCTD compilation process
  • 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
  • Target skill requirements for MS Office and Adobe Acrobat that apply across all electronic submission standards.
  • Gain clarity on the acronyms and jargon of eCTD and electronic submissions
  • Master the FDA standardization 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
  • Create quality control processes for documents and data to be included in your eCTD application

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This audio CD/Transcript of the webinar is a must for professionals in the drug industry, including:

  • Regulatory/legislative affairs professionals
  • Dossier managers
  • Strategic planning and business development staff
  • Data management and statistics personnel
  • Medical writers
  • Documentation/report services staff
  • Clinical project specialists
  • Compliance officers
  • Consultants/service providers/regulatory operations
  • Engineering and design control teams

Expert instructor, Antoinette Azevedo, founded e‑ 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.

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Read Rave Reviews from Past Attendees

What Previous Attendees Have to Say

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

"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

“With over 20 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‑ 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
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