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.
If you find yourself asking any of these questions — you’re not alone.
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
Order eCTD Requirements: Where Are You on The Curve? and you will:
This audio CD/Transcript of the webinar is a must for professionals in the drug industry, including:
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.
"Antoinette is extremely knowledgeable regarding needs across the industry."
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."
Director, Regulatory Submissions
“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."
Director, Operations and Regulatory Information Management, Regulatory Affairs
"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
"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!"
Manager, Regulatory Document Operations
Takeda Global Research & Development Center
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