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

When:  Jul 24, 2018 from 9:00 AM to 3:00 PM

Introduction to Electronic Regulatory Submissions in the eCTD Format

24 July 2018 (9:00 am–4:00 pm EST)
25 July 2018 (9:00 am–3:00 pm EST)

US Pharmacopeial Convention
Rockville, MD 20852

Do you need to comply with the 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:
24-25 July 2018

Meeting Location:
US Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD 20852

Registration Closes:
17 July 2018

Refund Deadline:
24 June 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 25 June 2018
RAPS Members: $1,250
Nonmembers: $1,350

Registration from 26 June 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 25 June 2018
RAPS Members: $1,250
Nonmembers: $1,350

Registration from 26 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:
24 June 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
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
All cancellation requests must be submitted to raps@raps.org by 24 June 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 10 July 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.

Location

12601 Twinbrook Pkwy
Rockville, MD 20852-1717