Simplifying Global Compliance
Submitting INDs in eCTD Format: Master Compliant Drug and Biologic Submissions
Held March 31, 2009
IND submissions are on the rise — up 22 percent over the last three years — and the FDA is scrutinizing every submission.
Preparing and submitting an IND to CDER in eCTD format comes with many unique challenges, such as:
- An IND submission that is provided over a longer period of time than other submissions requires a more comprehensive plan
- Data from the IND stage may be used and presented in ways later on that weren't initially planned
- How do you present preclinical/nonclinical study data
- Knowing the point at which you should establish communication with the FDA in preparation for an eCTD submission
Don't risk a delay in the start of your IND review because it fails the FDA validation check on eCTD submissions ... find the actionable information you need to meet all the challenges and properly file these submissions.
Let eCTD expert Antoinette Azevedo show you the steps you need to prepare and submit an IND in eCTD format during this 90-minute audio CD/Transcript. She'll explain the folder structure and content format for the document along with the navigation backbone standards. And she'll explain the FDA's perspective on INDs in eCTD format.
Antoinette will deliver the tips and tricks you need to master eCTD submission requirement.
Order now for your entire team to listen and discover:
- How an IND maps to the eCTD table of contents
- The benefits gained by sponsors who submit INDs electronically when transitioning to the process of submitting marketing applications (NDAs and BLAs)
- The folder structure, document content format and navigation backbone standards
- How to prepare compliant source documents and datasets for eCTD submissions
- What the FDA's perspective is on INDs in eCTD format
You'll have all the steps you need to take when preparing and submitting an IND in eCTD format.
This audio CD/Transcript is a must for professionals in the drug, biotech and biologic industry companies including:
- Compliance officers
- Consultants/service providers
- Data management and statistics personnel
- Engineering and design control teams
- Executive management
- R&D staff
- Dossier managers
- IT personnel who support regulatory staff
- Clinical affairs personnel
- Medical writers
- Regulatory/legislative affairs professionals
- Documentation/report services staff
- Clinical project specialists
- Clinical research associates
- Strategic planning and business development staff
- Study research coordinators
- Study sponsors
- Training personnel
, founder of e-Submissions Solutions.com, advises 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.
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