Introduction to Electronic Regulatory Submissions in the eCTD Format-April 2018

8.0
RAC Credits
Tuesday, 10 April 2018 (9:00 AM) - Wednesday, 11 April 2018 (3:00 PM)
7480 Miramar Rd Ste 202
San Diego, California, USA, 92126-4220
Until 12 March 2018:
Member Price: $1,250.00
List Price: $1,350.00

13 March 2018 and after:
Member Price: $1,350.00
List Price: $1,450.00

Introduction to Electronic Regulatory Submissions in the eCTD Format

10 April 2018 (9:00 am–4:00 pm PST)
11 April 2018 (9:00 am–3:00 pm PST)
New Horizons Learning Center
San Diego, CA 92126

Do you need to comply with the FDA's May 2018 electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . .

The deadline is fast approaching for your company to 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.


Program Dates:
10-11 April 2018

Meeting Location:
New Horizons Learning Center
7480 Miramar Road #202
San Diego, CA 92126


Registration Closes:
3 April 2018

Refund Deadline:
11 March 2018

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:
Registration to 12 March 2018
RAPS Members: $1,250
Nonmembers: $1,350

Registration from 13 March 2018 
RAPS Members: $1,350
Nonmembers: $1,450

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people.


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 fast-approaching FDA electronic submission deadlines for eCTD in 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.


Registration Info

NOTE: The training facility will provide each student with computers for this program.

Registration to 12 March 2018
RAPS Members: $1,250
Nonmembers: $1,350

Registration from 13 March 2018
RAPS Members: $1,450
Nonmembers: $1,550

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 30 people.

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:
11 March 2018

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
San Diego International Airport (18 miles)


Area Hotels

The following hotels are located near the New Horizons Training Center.

San Diego Marriott La Jolla
4240 La Jolla Village Drive
La Jolla, California 92037 USA
Reservations: 1-858-587-1414

Hyatt Regency La Jolla at Aventine
3777 La Jolla Village Drive
San Diego, California, USA, 92122
Reservations: 1-858-552-1234

Holiday Inn Express & Suites San Diego-Sorrento Valley 
5925 Lusk Blvd.
San Diego, California 92121 USA
Reservations: 1-858-731-0100


Cancellation

All cancellation requests must be submitted to raps@raps.org by 11 March 2018. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed.

Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 27 March 2018

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.

RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing. Supporting documentation is required and must be received by the posted deadline. All refunds are subject to a 20% assessment unless otherwise specified.

Please send your cancellation information, with documentation, the name of the person registered, customer (or member) number and event title via email, to raps@raps.org.

Substitutions may be accepted with written approval from RAPS.



Register