Navigating the FDA's New Requirements for eCTD SubmissionsMastering the Tools and Strategies: An Interactive Workshop
the FDA's New Requirements for eCTD Submissions
Mastering the Tools and Strategies: An Interactive Workshop
Hilton San Diego Resort • San Diego, CA • Oct. 1-2, 2007
Requiring eCTDs for CDER electronic submissions is only the beginning. Are you and your staff prepared?
The FDA is moving quickly toward establishing an all-electronic system environment. So quickly that it even held a meeting on Part 15, taking the place of any pre-rulemaking activities and giving the FDA the authority to go straight to a final rule.
Join us for two days of intensive training to educate drug, device and biologics personnel with the knowledge and expertise needed to electronically file eCTDs with the FDA. Through a series of interactive exercises, case studies and small group discussions, you'll leave knowing how to produce an eCTD, how to manage an eCTD and where the FDA is headed next.
In Navigating the FDA's New Requirements for eCTD Submissions, you will:
- Discover the top 12 reasons sponsors receive a refuse-to-file (RTF) 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
- 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
- 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 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
Vice President, Worldwide Regulatory Operations, Pfizer
Click here to read more comments from your colleagues.Your valuable course materials book is packed with tools you can put to use right away, including:
what your colleagues say
"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 ten 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
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