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.
Attend Preparing for New Electronic Submission Deadlines and you will:
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:
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
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
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
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.
"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, Hoffmann–La 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
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