Navigating the FDA's New Requirements for eCTD Submissions Mastering the Tools and Strategies: An Interactive Workshop
Product Details
Navigating the FDA's New Requirements for eCTD Submissions
Mastering the Tools and Strategies: An Interactive Workshop
Radisson Plaza-Warwick Hotel Philadelphia • Philadelphia, PA • July 28-29, 2008
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.
Through
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:
- Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions
- Gain clarity on the acronyms and jargon of eCTD and electronic submissions
- Effectively budget and develop project plans for eCTD submissions
- Understand why and how to start producing eCTD submissions at the IND phase
- Master the documentation requirements for electronic datasets for stability, nonclinical and clinical, and better communicate these requirements to colleagues early in the drug development cycle
- Assure the output of your in-house system is valid for FDA review
- 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 and how to prepare to submit your eCTDs electronically
- Create quality control checklists for documents and data to be included in your eCTD application
- Develop a cost-justification for outsourcing or purchasing an eCTD system and know how to control your budget and avoid out of scope charges when outsourcing your eCTD
- Develop a business case for electronic document management systems (eDMS) as part of your total solution for eCTD submissions
- Analyze cost and timelines for selection, implementation and validation of eCTD publishing systems and understand who the vendors are and their products' distinguishing characteristics
- Understand the interdependencies of submission life cycle and document management systems in combination with eCTD publishing systems and the importance of submission life cycle management
- Preview eCTD: The Next Generation — Regulated Product Submissions (RPS)
"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 Hoffman-LaRoche |
Click here to read more comments from your colleagues.
Your valuable course materials CD is packed with tools you can put to use right away, including:
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Here's what your colleagues say
"Antoinette's
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
"Antoinette
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
learning experience."
Workshop attendee, 2007
"Antoinette
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
reports."
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."
John Oidtman
Vice President, Worldwide Regulatory Operations, Pfizer
"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 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
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
"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
"Microbia
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."
Christine Pierce
Manager of Regulatory Affairs
Microbia
"Antoinette
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."
Liam Curran
Associate Director, Regulatory Operations
Gilead Sciences