Learn the Entire Spectrum of eSubmissions (1st Quarter 2020)

$1,450.00

February 24-26, 2020

Registration for this course will CLOSE February 14, 2020.

After February 14, please call 619-876-2520 to check for enrollment availability.

Category:

This course is intended for adult learners with little or no experience in eSubmissions. It covers the entire spectrum of eSubmissions from beginning to end, i.e., the final submission.

The course content is divided into:
• Pre-publishing: e.g., templates, bookmarks/hyperlinks, and scanning standards
• Publishing: e.g., hyperlinks between documents, check sums and validator use
• Post Publishing: e.g., electronic gateway accounts and re-use of document content

Please bring either a Windows laptop or MAC with you to this course.

SpringHill Suites Mission Valley
2401 Camino Del Rio North
San Diego, CA 92108

Contact Miguel Pulido for your discounted hotel room rate:

email: Miguel.Pulido@marriott.com
phone: 619.881.0293

ALSO PLEASE INFORM HIM of Vegan or Vegetarian food preferences and any food allergies.

SpringHill Suites Mission Valley
2401 Camino Del Rio North
San Diego, CA 921083
Phone: 619.881.0293

Monday, February 24 – Day 1

Time Activity Topics to Be Covered Type of Activity Lead Instructor
8:00-9:00 Registration & breakfast
9:00-9:30 Opening remarks Lecture Al Edwards
9:30-10:00 Overview of eCTD eCTD history

eCTD standards & validation
eCTD organization		 Lecture + demonstration Mitch Seymour
10:00-10:15 Break
10:15-12:00 Role of MS Word and Adobe Acrobat in preparing submission content FDA PDF specifications

Use of MS Word templates

MS Word to PDF conversion using PDFMaker		 Lecture + hands-on exercises Mitch Seymour
12:00-1:00 Lunch
1:00-2:00

Mapping legacy paper submission to eCTD

Where does the content go?
How much content is required – DMF II-III-IV and FDA vs Health Canada?
Granularity strategy

 Lecture + demonstration Katherine Ullman
2:00-3:00 eCTD assembly & Quality Control

Create initial eCTD sequence
Set Administrative attributes
Add submission content

 Lecture + hands-on exercises Antoinette Azevedo
3:00-3:15 Break
3:15-4:45 eCTD assembly & Quality Control, continued

Validate eCTD submission
Correct validation errors & republish

 Lecture + hands-on exercises Antoinette Azevedo
4:45-5:00 Q&A and discussion Antoinette & Mitch

Tuesday, February 25 – Day 2

Time Activity Topics to Be Covered Type of Activity Lead Instructor
7:30-8:30 Breakfast
8:30-10:00 eCTD Quality Control eCTD Validation

Consequences of noncompliant PDF files		 Lecture + demonstration Antoinette Azevedo
10:00-10:15 Break
10:15-12:00 eCTD assembly

Create the next eCTD sequence
Add submission content to Module 2
Add submission content and metadata to Modules 3-5
Add External hyperlinking
Validate eCTD submission

 Lecture + hands-on exercises Antoinette Azevedo
12:00-1:00 Lunch
1:00-3:00 eCTD best practices

MS Word checklist
PDF checklist
eCTD project plans
eCTD checklist
Bookmarking & hyperlinking standards
Leaf title standards
Handling content from multiple sources

 Lecture + demonstration Mitch Seymour
3:00-3:15 Break
3:15-4:45 eCTD lifecycle management

Amendments, annual reports, Safety Report
Consequences of early decisions on downstream lifecycle management
Additional external hyperlinking

 Lecture + hands-on exercises Antoinette Azevedo
4:45-5:00 Q&A and discussion Antoinette & Mitch

Wednesday, February 26 – Day 3

Time Activity Topics to Be Covered Type of Activity Lead Instructor
7:30-8:30 Breakfast
8:30-10:00 Datasets & CRFs Electronic datasets, CDISC standards, PopPK datasets, CRFs Lecture + demonstration Antoinette Azevedo
10:00-10:15 Break
10:15-11:00 eCTD Fundamentals

How to operationalize eCTD publishing
Outsourcing vs in-house production
Infrastructure options
ESG & eSubmission Portals
eCTD Pilot
Electronic signatures
Digital certificates
EDMS
PDF rendering options
Legacy submission to eCTD mapping

 Lecture + hands-on exercises Mitch Seymour
11:00-11:45 eCTD Metrics & communicating with management
Change Management 		Lecture Antoinette, Mitch & Al
11:45-12:00 Discussion, class wrap-up and conclusion All hands

Reviews

  1. Kristi H. –

    I indeed enjoyed the class and learned so much valuable information. I just now need to put it into action. – Kristi H.

  2. Che J. –

    I had a great time at the workshop… thx again! – Che J.

  3. Mike B. –

    Thanks for a terrific training course. – Mike B.

  4. Lisa S. –

    I wanted to thank everyone involved with the class… I felt it created a solid base for my continued education in the world of regulatory publishing. – Lisa S.

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