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Updated eSubmission Roadmap (v.2.1)

Updated eSubmission Roadmap (v.2.1)

liane-varnes
0 Slides

Adopted . by . HMA . on 28.02.2018. The stepwise ...

MHRA baseline guidanceA baseline submission refers to submission of al

MHRA baseline guidanceA baseline submission refers to submission of al

winnie
4 Slides

Harmonised Technical Guidance for eCTDSubmissions ...

Guidance for Industry Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications DRAFT GUIDANCE This

Guidance for Industry Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications DRAFT GUIDANCE This

kittie-lecroy
14 Slides

Comments and suggestions regarding this draft doc...

Specifications for File Format Types Using eCTD Specifications
...

Specifications for File Format Types Using eCTD Specifications ...

alexa-scheidler
100 Slides

Version Summary of Changes Initial version 1 S...

The eCTDBackbone Files Specification for Module 1��Version 2.3The eCTD

The eCTDBackbone Files Specification for Module 1Version 2.3The eCTD

briana-ranney
100 Slides

Date Version Summary of Changes 2003 - 08 - 13 ...

1 &#x/MCI; 5 ;&#x/MCI; 5 ;Submitting High Quality eCTD Submiss

1 &#x/MCI; 5 ;&#x/MCI; 5 ;Submitting High Quality eCTD Submiss

myesha-ticknor
100 Slides

2 &#x/MCI; 5 ;&#x/MCI; 5 ;FDA Disclaimer...

TRANSMITTING ELECTRONIC SUBMISSIONS USING eCTD SPECIFICATIONSTechnial

TRANSMITTING ELECTRONIC SUBMISSIONS USING eCTD SPECIFICATIONSTechnial

min-jolicoeur
100 Slides

U.S. Department ofalth and Human ServiFood and rug...

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