Introduction to Regulatory Submissions in eCTD Format–April 2017

If you are new to preparing submissions documents for FDA, this is the introductory course that will begin your understanding of the steps you need to comply with the May 2017 electronic submission requirements.

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 processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:

  • Submission acronyms and eCTD jaron
  • Different submission types
  • Which applications need to be submitted electronically
  • How to follow the eCTD structure
  • Agency-compliant PDF files and how to generate them
  • Which agency guidelines and technical specifications publishers need to follow
  • What is required to electronically submit your applications
  • How to plan a successful eCTD submission

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




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Faculty
  • Registration Info
  • Cancellation

At a Glance

Date:

10 April 2017 (9:00 am–4:00 pm EST), 11 April 2017 (9:00 am–12:00 pm EST)

Meeting Location:

US Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD

Registration Closes:

3 April 2017

Refund Deadline:

10 March 2017

RAC Credits:

8

Will this meeting be recorded?

No

Proof of Attendance:

An electronic letter of attendance will be sent upon request.

Registration Fees:

Registration to 10 February 2017
RAPS Members:  $1,250
List:  $1,350

Registration from 11 February to 3 April 2017
RAPS Members:  $1,350
List:  $1,450

 

NOTE: 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 35 people. 

» More Meeting FAQs

Objectives

At the conclusion of this program, participants will be able to:

  • Understand the acronyms and terms surrounding electronic submissions
  • Break down the eCTD structure using the M4 guidances (ICH)
  • Identify best practices with software used to generate electronic submission content
  • Produce MS Word and PDF documents that meet FDA guideline
  • Obtain a basic understanding of what is required to transition into submitting in the eCTD format
  • Learn the basics of managing an electronic submissions project
    • Assemble a basic planner for an eCTD submission
      • Apply for an Electronic Submissions Gateway) ESG test account

      Who Should Attend

      This introductory class is for beginners in regulatory submissions, those who are changing positions and learning to prepare submissions documents for FDA, and for those who are more experienced and need a review. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge of the CTD structure and M4 guidances that govern the organization of the eCTD to meet the fast-approaching FDA electronic submission deadlines in May 2017.  

      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.

      Agenda

      Agenda

      Day 1

      • Define important CTD and eCTD submission terminology 
      • Provide a detailed breakdown of the CTD structure
      • Understand the M4 guidances (ICH) and FDA Technical Specifications 
      • Provide a detailed breakdown of the modular format of the eCTD backbone 
      • Learn how to set up a planner for submission content 
      • Learn tips, tricks and best practices 

      Day 2

      • Learn how to create FDA-compliant PDF documents using MS Word best practices, and how to remediate existing PDF files
      • Review the workflow process by incorporating document publishing into your submission planner
      • Learn what will be required to convert from a paper application to an eCTD application
      • Learn how to apply for an Electronic Submissions Gateway Account (ESG)
      • Learn tips, tricks and best practices

      NOTE: Program content may vary.

      NOTE: Laptops are required. RAPS does not supply laptop equipment for attendees. 

       

      Faculty

      Nora Keeling, regulatory submissions QC and planning, Mentara Inc. 

      Marianne Mowrer, regulatory submissions specialist, Mentara Inc.

      Registration Info

      IMPORTANT: Attendees must bring their own laptops. RAPS does not provide equipment for attendees. Apple computers are discouraged.

       

      Registration to 10 February 2017
      RAPS Members:  $1,250
      List:  $1,350


      Registration from 11 February to 3 April 2017

      RAPS Members:  $1,350
      List:  $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 35 people. 

       

      » Registration Online
      » Registration Form (PDF) - for registration by 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: 10 March 2017

      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

      Chris Hall
      chall@raps.org
      +1 301 770 2920, ext. 222  

      Parking
      Paid parking is available in the parking building directly behind 5635 Fishers Lane in Rockville (next door to US Pharmacopeial Convention).

      Area Airports
      Ronald Reagan Washington National Airport (24 miles) 
      Washington Dulles International Airport (36 miles)
      Baltimore-Washington International Airport (37 miles)

      Area Hotels
      The following hotels are located near US Pharmacopeial Convention.

      Even Hotel Rockville (Walking Distance)
      1775 Rockville Pike
      Rockville, MD 20852
      Reservations: +1 877 834 3613

      Hilton Washington DC/Rockville Hotel (Walking Distance) 
      1750 Rockville Pike
      Rockville, MD 20852
      Reservations: +1 301 468 1100

      Bethesda North Marriott Hotel
      701 Marinelli Road
      Bethesda, MD 20852
      Reservations: +1 301 822 9200

      Bethesda Marriott Suites
      6711 Democracy Boulevard
      Bethesda, MD 20817
      Reservations: +1 800 228 9290

      Washington Metro Access
      The Twinbrook Metro Station is a short walk to 12601 Twinbrook Parkway. Take the Red Line to the Twinbrook Metro Station.

      Cancellation

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

      Please send your cancellation information, with documentation, specifying 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.