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9th Annual eSubmissions: Transitioning to eCTDs - Regulatory, Resource and Technical Challenges

Event Information

May 17 - 19, 2006 | , ,

 



Doc Title

Online Documentation

Online Documentation

This page will be used to provide paid delegates of the conference with access to any presentations that were not included in the conference documentation. Only paid conference delegates have permission to access IIR online documentation.

While these presentations were not available to be included in your conference documentation, IIR is pleased to make them available to all conference delegates through this web site.

You will need the freely available Adobe Acrobat Reader, which is available by clicking here. To access the presentations:

  • Click the title of the session
  • You can choose to view the file online or save the file to your computer
  • You can print the files and add them to your other conference materials

FDA Electronic Standards
Joseph Montgomery, Lead IT Specialist, FOOD AND DRUG ADMINISTRATION

E-Submissions for the Smaller Company
Guy Pawson, Manager, Development Electronic Submissions, GENENTECH

Measuring the Return On Investments in Electronic Submissions
William Qubeck, Associate Director of Electronic Submissions Support Services, PFIZER INC

SAFE: The Key to Identity Management and Digital Signatures
Mollie Shields-Uehling, President, SAFE-BioPharma Association

eCTD - Expectations, Reality and Understanding
Sarah Powell, Executive Director, Regulatory Strategies, Thomson Scientific

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