Intermediate Course for Regulatory Submissions in eCTD Format–July 2018

10.0
RAC Credits
Thursday, 26 July 2018 (9:00 AM) - Friday, 27 July 2018 (3:00 PM)
12601 Twinbrook Pkwy
Rockville, Maryland, USA, 20852-1717
Until 27 June 2018:
Member Price: $1,350.00
List Price: $1,450.00

28 June 2018 and after:
Member Price: $1,450.00
List Price: $1,550.00

Intermediate Course for Regulatory Submissions in eCTD Format

26 July (9:00 am–4:00 pm EST)
27 July (9:00 am–3:00 pm EST)

US Pharmacopeial Convention
Rockville, MD 20852

If you are currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the FDA's May 2018 electronic submission requirements, this course is for you.

Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet these new requirements, organizations need to understand the processes required to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:

  • How to comply with the May 2018 electronic submissions requirements
  • Which agency guidelines and technical specifications publishers need to follow
  • How to apply ICH and regional requirements to your eCTD
  • How to compile documents into the XML backbone of an eCTD, and lifecycle that application
  • How to QC and validate an eCTD
  • How metadata and study tagging files work
  • Tips, tricks and best practices gathered from industry professionals
  • How convert from a paper application to an eCTD
  • How the new Module 1 (version 3.3) can be used for regulatory submissions
  • What CTD readiness really means

We will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW), and give you a basic understanding how the regions differ.

Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance.

Program Dates:
26-27 July 2018 

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

Registration Closes:
20 July 2018

Refund Deadline:
26 June 2018

RAC Credits:
10 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 27 June 2018
RAPS Members: $1,350
Nonmembers: $1,450

Registration on or after 27 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.


Objectives

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

  • Identify best practices with software used to generate electronic submission content
  • Understand the acronyms and terms surrounding eCTD and electronic submissions
  • Apply ICH and regional requirements for the content of an eCTD submission
  • Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA.
  • Obtain an understanding of what is required to transition into submitting in the eCTD format.


Who Should Attend

This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to comply with the May 5, 2018 FDA electronic submission deadline.

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

  • How to comply with the May 2018 electronic submission requirements
  • Guidances that govern electronic submissions
  • How to electronically submit to FDA
  • Generating compliant PDF files—best practices in MS Word and Adobe Acrobat
  • Hands-on compilation of an eCTD
    • Module 1 differences between US and Rest of World
    • Creating the initial sequence of an application
    • Assigning the metadata required by the regional authority and ICH
    • Lifecycling the application
    • Publishing and validating the application
  • Compiling will include:
    • Study Tagging Files (STFs)
    • Datasets
    • SPLs (Structured Product Labeling)
    • Granulated Clinical Study Reports (gCSR)
  • Challenges with preparing compliant eCTD submissions
  • Review and QC of the compiled application
  • Common and avoidable errors that could get your submission rejected
  • Tips, tricks and best practices gathered from industry professionals
  • Converting from a paper application to an eCTD application
  • What eCTD readiness really means

NOTE: Program content may vary.

NOTE: EACH PARTICIPANT MUST BRING HIS/HER OWN LAPTOP FOR USE DURING THE CLASS

Faculty
Elsmari Eggers, head of training and RA consulting, LORENZ Life Sciences
Nora Keeling, MS, QC and regulatory submission consultant, Mentara Inc.
Jared Lantzy, PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences
Marianne Mowrer, regulatory submissions specialist, Mentara Inc.


Registration Info

IMPORTANT: EACH PARTICIPANT MUST BRING HIS/HER OWN LAPTOP FOR USE DURING THE CLASS. RAPS does not supply computer equipment for attendees.

Registration to 19 July 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:
26 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. 252

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 26 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 12 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.

Register