Udemy - USFDA Electronic Submission Gateway

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[ CoursePig.com ] Udemy - USFDA Electronic Submission Gateway
  • Get Bonus Downloads Here.url (0.2 KB)
    • ~Get Your Files Here ! 01 - Introduction
    • 001 Introduction.mp4 (32.8 MB)
    • 002 Overview of Registration Process.mp4 (39.9 MB)
    02 - Preparatory Activities
    • 001 Letter of Non Repudiation Agreement.mp4 (32.6 MB)
    • 002 Obtaining Digital Certificate.mp4 (38.3 MB)
    • 003 Understand Submission Guidelines.mp4 (50.3 MB)
    • 004 Naming Conventions.mp4 (6.1 MB)
    • 005 Determine Submission Methods.mp4 (42.0 MB)
    • 006 Connection Requirements.mp4 (18.1 MB)
    • 39858010-ADI-Definitions-0.pdf (148.3 KB)
    • 39858054-FDA-ESG-ADI-Dashboard-Pocket-Guide.pdf (322.0 KB)
    • external-assets-links.txt (1.4 KB)
    03 - FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS
    • 001 FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS.mp4 (57.7 MB)
    • 39858160-Registering-for-an-AS2-test-account.docx (274.6 KB)
    • 39858198-Sending-a-WebTrader-Test-Submission.docx (863.5 KB)
    • 39858218-Registering-for-a-WebTrader-Test-Account.docx (304.2 KB)
    • external-assets-links.txt (0.1 KB)
    04 - Congratulations and Thank you
    • 001 Congratulations and Thank you.mp4 (11.6 MB)
    • Bonus Resources.txt (0.4 KB)

Description

USFDA Electronic Submission Gateway



https://CoursePig.com

MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 331 MB | Duration: 54m

USFDA, ESG, eCTD, PSUR, Electronic communication, Data submission tool, Regulatory affairs,

What you'll learn
USFDA-Electronic submission gateway
Submission of electronic information to USFDA
Submission of eCTD through online submission tool
Preparation activities for submission
Application for account generation
Regulatory affairs
Guidance for Approval of Pharmaceutical Product
Generic pharmaceutical product registration
Electronic communication between USFDA and Applicant
Requirements
Pharmacy Profession
Regulatory affairs associate
Pharmaceutical industry Background
Curiosity towards learning
Science education
Description
If you Regulatory affairs profession and you are not aware about ESG (Electronic Submission gateway, then this course will make you specialist in handling regulatory hurdles. You can easily get Approval for your registered product in less time.

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions.



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331.2 MB
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Udemy - USFDA Electronic Submission Gateway

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Download torrent
331.2 MB
seeders:1
leechers:4
Udemy - USFDA Electronic Submission Gateway

Torrent hash: 8EB6B9F6B6856782505E1F35D197DBF2E8235F5F