Paper submissions are losing traction and that's no secret. Every day, regulatory authorities across the globe are turning to electronic submissions as their new preferred format ... and the FDA is leading the way.
With RPS (Regulated Product Submission) poised to build on the eCTD standard, if you don't yet have your electronic submission process perfected, there's no time to lose.
Many drug, biologic and device companies can already measure the difference in dollars, through increased first-time acceptance rates ... shorter FDA review times ... and yes, speed to market.
Your colleagues and competitors have found the key.
You can, too, in this hands-on workshop that gives you the eCTD tools and tactics to satisfy any regulator worldwide, plus prepare for RPS.
Don't delay. Register now and mark your calendar for Preparing for the New Global Requirements
for eCTD and Regulated Product Submissions.
Attend Preparing for the New Global Requirements for eCTD and Regulated Product Submissions and you will:
walk away from this interactive workshop with presentation slides
Here's what previous attendees have to say:
"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
|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.
May 13–14, 2010
Marriott Raleigh Crabtree Valley
4500 Marriott Drive
Raleigh, NC 27612
Telephone: +1 (919) 781-7000
Toll Free: (800) 228-9290
Room rate: $149.00 (plus 12.75% tax)
Reservation cutoff date: April 21, 2010
Register Early — Space is LimitedHurry — 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.
Send Your Team for Maximum Benefit
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 from 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.
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