Introduction to Electronic Regulatory Submissions in the eCTD Format - February 2019

8.0
RAC Credits
Tuesday, 12 February 2019 (9:00 AM) - Wednesday, 13 February 2019 (4:00 PM) (Eastern Time (US & Canada))
9630 Gudelsky Drive
Rockville, Maryland, USA, 20850-3481
Introduction to Electronic Regulatory Submissions in the eCTD Format

12 February 2019 (9:00 am–4:00 pm ET)
13 February 2019 (9:00 am–4:00 pm ET)

The Universities at Shady Grove
9630 Gudelsky Drive, Building II
Room 1042
Rockville, MD 20850

Do you need to ensure your company’s compliance with the May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . .

Then this workshop is your first stop to learn all you need to know to help your company migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications.

During this workshop, you will learn:
• Different submission types
• Which applications need to be submitted electronically
• How to understand and follow the CTD structure
• How to use the M4 series of guidances and granularity to generate compliant submissions
• Agency-compliant PDF files and how to generate them
• Which agency guidelines and technical specifications publishers need to follow
• What tools are required to electronically submit your applications

Join us for this two-day training that will answer your eCTD questions and help you get on a direct path to compliance.

Registration Closes: 8 February 2019
Refund Deadline: 13 January 2019
RAC Credits: 8 RAC recertification credits upon completion of the program

Will this meeting be recorded? No
Proof of Attendance: An electronic letter of attendance will be sent upon request.  

Registration Fees to 14 January 2019
RAPS Members: $1,050 
Nonmembers: $1,150 

Registration from 15 January to 8 February 2019
RAPS Members: $1,150
Nonmembers: $1,250

Advance registration is required for this workshop and participants are encouraged to register early.

Objectives & Audience Objectives

After this program, participants will be able to:
•Understand the acronyms and terms surrounding electronic submissions
•Break down the CTD structure using the M4 guidances (ICH) in preparation for eCTD
•Identify best practices with software used to generate electronic submission content
•Produce MS Word and PDF documents that meet FDA guidelines
•Obtain a basic understanding of what is required to transition into submitting in the eCTD format

Who Should Attend

The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in the CTD format in preparation for electronic submissions to meet the FDA electronic submission deadlines for eCTD that took effect May 2018. This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing. There are no prerequisites for participation.

Agenda
•Define important terminology used in e-submissions
•Provide a detailed breakdown of the CTD structure
•Understand the M4 guidances (ICH) and FDA Technical Specifications
•Learn how to create FDA-compliant MS Word documents
•Learn how to create FDA-compliant PDF documents from differing sources
•Review the workflow process using planners to produce an eCTD
•Learn how to convert from a paper application to an eCTD application
•Learn the basics of managing an electronic submissions project
•Review the entire Lifecycle of an electronic submission from first steps to eCTD
•Learn tips, tricks and best practices
•What does eCTD readiness mean?

NOTE: Program content may vary.

Faculty
Marianne Mowrer, regulatory submissions specialist, Mentara Inc.
Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc.

You may register for this workshop via mail or fax if it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.

Refund Deadline: 13 January 2019

Other Information: 
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Program Contact: 
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, ext. 291

Area Airports
Washington Reagan Airport (DCA)
Washington Dulles International Airport (IAD)
Baltimore-Washington International Airport (BWI)

Area Hotels
The following hotels are located near The Universities at Shady Grove.

Hilton Garden Inn Rockville
14975 Shady Grove Road
Rockville, MD 20850
(240) 507-1800

Courtyard by Marriott Rockville
2500 Research Boulevard
Rockville, MD 20850
(301) 670-6700

Radisson Hotel Washington DC - Rockville
3 Research Center 
Rockville, MD 20850
(301) 840-0200

Cancellations
All cancellation requests must be submitted to raps@raps.org by 13 January 2019
A 20% cancellation fee will be assessed. Please specify the name of the person registered and event title. RAPS is unable to accept cancellations by phone. Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 29 January 2019

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org. NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.


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