Learn the Entire Spectrum of eSubmissions (Fall 2019)

$1,450.00

October 23-25,2019

Registration for this course will CLOSE October 5, 2019.

After October 5, 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.

Holiday Inn Express Springfield Downtown
145 State Street
Springfield, MA 01103
Phone: (413) 285-8436

La Quinta Inn & Suites Springfield
100 Congress St
Springfield, MA 01104
Phone: (413) 781-0900

MGM Springfield
One MGM Way [State Street & Main Street]
Springfield, MA 01103
Phone: (413) 273-5000

Sheraton Springfield Monarch Place Hotel
One Monarch Place [1414 Main Street]
Springfield, MA 01104
Phone: (413) 781-1010

Court Square Group, Inc.
1350 Main St., Fifth Floor
Springfield, MA 01103
Phone: (413) 746-0054

Approximately 20 minute drive from Bradley Int’l Airport, Hartford, CT.

Wednesday, October 23– Day 1

Time Activity Topics to Be Covered Type of Activity Lead Instructor
8:00-9:00 Registration
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

Thursday, October 24 – Day 2

Time Activity Topics to Be Covered Type of Activity Lead Instructor
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

Friday, October 25 – Day 3

Time Activity Topics to Be Covered Type of Activity Lead Instructor
8:30-10:00 Datasets & CRFs Electronic datasets, CDISC standards, PopPK datasets, CRFs Lecture + demonstration Antoinette Azevedo
10:00-10:15 Break
10:15-12:00 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
12:00-1:00 Lunch
1:00-2:00 eCTD Metrics & communicating with management Al Edwards
2:00-3:00 Change Management   Lecture Antoinette, Mitch & Al
3:00 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.

Add a review

Your email address will not be published. Required fields are marked *