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:

  • 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

We will also briefly discuss European, Canadian and US guidelines, and help you gain a basic understanding about each region.

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
Nonmembers:  $1,350

Registration from 11 February to 3 April 2017
RAPS Members:  $1,350
Nonmembers:  $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 guidelines
  • Obtain a basic understanding of what is required to transition into submitting in the eCTD format

Who Should Attend

This introductory class is for beginners in regulatory, 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 in electronic submissions 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

  • Define important terminology used in e-submissions
  • Provide a detailed breakdown of the eCTD structure
  • Understand the M4 guidances (ICH) and FDA Technical Specifications
  • Learn how to create FDA-compliant MS Word documents
  • 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 Life Cycle of an electronic submission from first steps to eCTD
  • Learn the basics of managing an electronic submissions project
  • Review the entire Life Cycle 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.

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


Faculty

Marianne Mowrer, regulatory submissions specialist, Mentara Inc.

Nora Keeling, MS, consultant, 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
Nonmembers:  $1,350


Registration from 11 February to 3 April 2017

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 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

John Brown
jbrown@raps.org
+1 301 770 2920, ext. 215

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.