Register today to get the training you need to produce, manage and present correct, compliant eCTDs.
In this intensive
two-day workshop, you’ll receive step-by-step instruction and hands-on
training from industry leader Antoinette Azevedo. With more than 20 years
of experience, Antoinette has dedicated her career to helping companies
including Takeda Pharmaceutical, sanofi pasteur and Microbia gain a thorough
understanding of electronic submission technologies.
a series of interactive exercises, case studies and small group discussions,
she will show you how to produce an eCTD, how to manage an eCTD and where
the FDA is headed next. You’ll learn eCTDs from A to Z, from contents
and characteristics to vendors and validation.
Plus, you'll receive an indispensable CD of course materials that you can put to use immediately, along with presentation slides! Click here to see the entire list of essential information included on the CD.
Space Is Limited — Register Today!
In Navigating the FDA's New Requirements for eCTD Submissions, you will:
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
Click here to read more comments from your colleagues.
Your Team for Maximum Benefit
"Antoinette knows her eCTD and submissions overall. I'm very glad I chose this course — it was very educational. She was the best instructor, very interesting. Thank you very much…this was one of the BEST trainings I have been to in years."
Publishing Coordinator, Sanofi-Aventis
"Antoinette is extremely knowledgeable regarding needs across the industry."
Report Coordination Supervisor, SNBL USA
range and depth of knowledge on this subject is amazing. At every turn
she provided practical tips and tricks. She told of the pitfalls that
a sponsor should look for. Conferences seem to provide a high level overview.
Not so with Antoinette — the level of detail she provided was enormously
valuable. I can't imagine someone who knows more on this particular subject.
My company may ask her to consult for us."
Workshop attendee, 2007
was extremely knowledgeable in terms of both technology and regulatory
requirements. It was a lot of material in a single class. It was a great
Workshop attendee, 2007
knows what she is discussing and has a lot of knowledge to share. I loved
receiving a CD which had guidelines and more information about eCTD. I
liked going over an eCTD and reviewing errors and XML so that I can troubleshoot
Workshop attendee, 2007
"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."
Vice President, Worldwide Regulatory Operations, Pfizer
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."
Director, Operations and Regulatory Information Management, Regulatory Affairs
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
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
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
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."
Manager of Regulatory Affairs
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."
Associate Director, Regulatory Operations
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.
Dec. 8-9, 2008 • Raleigh, NC
Marriott Raleigh Crabtree Valley
4500 Marriott Drive
Raleigh, NC 27612
Telephone : +1 (919) 781-7000
Toll free (800) 228-9290
Fax: +1 (919) 781-3059
Room rate: $149 (plus 12.75% tax)
Hotel reservation cutoff date: Nov. 16. 2008
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.
Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.
Written cancellations received at least one week prior to the start date of the event will receive a 100% refund or credit toward a future FDAnews event. After that time, refunds will be subject to a $200 administration fee. 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.
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