ComplianceOnline

Preparing Compliant eCTD Submissions

Instructor: Antoinette Azevedo
Product ID: 700719
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2008

Training CD / USB Drive

$500.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions.

Description

The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.

FDA has issued Refuse-to-File (RTF) notices to sponsors who submitted noncompliant eCTDs, which resulted in sharp drops in market capitalization of those sponsor’s companies, months of time and effort to prepare the eCTD for resubmission, and potentially millions in dollars of lost revenue from overall delays in FDA review.

Areas covered in the webinar:

  • Understand requirements for electronic submissions -- eCTD, SPL/PIM, CDISC.
  • Understand how the agencies perform reviews on electronic submissions.
  • Evaluate your company's technical resources (software, network, document management) to prepare eCTD submissions.
  • Evaluate your company's business policies concerning records management and document management and their impact to preparing eCTD submissions.
  • What approaches can you take to prepare eCTD submissions including outsourcing all or part of the process?
  • How to validate compliance of your eCTD with FDA and ICH guidances?

Who will benefit:

This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products. The employees who benefit include:

  • Regulatory Affairs strategists
  • Regulatory Operations
  • Information Technology managers and personnel
  • Quality, Nonclinical and Clinical staff managing deliverables from internal and external suppliers that will make their way into eCTD
  • Medical writing

Instructor Profile:

Antoinette Azevedo, founded e-SubmissionsSolutions.com (a California corporation) to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies -- all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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