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

8.0
RAC Credits
Tuesday, 13 November 2018 (9:00 AM) - Wednesday, 14 November 2018 (3:00 PM) ()
7480 Miramar Rd Ste 202
San Diego, California, USA, 92126-4220

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

13 November 2018 (9:00 am–4:00 pm PST)
14 November 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 CTD questions and help you get on a direct path to compliance.

Program Dates:
13-14 November 2018

Meeting Location:
New Horizons Learning Center   
7480 Miramar Drive  
San Diego, CA 92126

Registration Closes:
6 November 2018

Refund Deadline:
14 October 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 15 October 2018
RAPS Members: $1,250
Nonmembers: $1,350

Registration from 16 October 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 15 October 2018
RAPS Members: $1,250
Nonmembers: $1,350

Registration from 16 June 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:
14 October 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

Parking 

Ample parking is available at the training center. 

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

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 14 October 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 30 October 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.

Register