Intermediate Course for Regulatory Submissions in eCTD Format - February 2019

10.0
RAC Credits
Thursday, 14 February 2019 (9:00 AM) - Friday, 15 February 2019 (4:00 PM) (Eastern Time (US & Canada))
9630 Gudelsky Drive
Rockville, Maryland, USA, 20850-3481

Intermediate Course for Regulatory Submissions in eCTD Format

14 February 2019 (9:00 am–4:00 pm ET)
15 February 2019 (9:00 am–4:00 pm ET)

The Universities at Shady Grove
9630 Gudelsky Drive, Building II 
Room 1042
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 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.

Registration Closes: 8 February 2019
Refund Deadline: 16 January 2019
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.

Objective
s - 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.

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 Information:  Students will need to bring their own laptops.

Registration to 16 January 2019  
RAPS Members:  $1,150 
Nonmembers:  $1,250

Registration from 17 January to 8 February 2019
RAPS Members:  $1,250
Nonmembers:  $1,350

Advance registration is required for this workshop and we recommend that you register early. RAPS is unable to accept onsite registrations. 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: 16 January 2019 

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

Area Airports
Washington Reagan Airport (DCA)
Washington Dulles International Airport (IAD)
Baltimore Washington International Airport (BWI)

Area Hotels
The following hotels are located near the The Universities at Shady Grove.

Hilton Garden Inn Rockville
14975 Shady Grove Road
Rockville, MD 20850
(240) 507-1800

Courtyard by Marriott Rockville
2500 Research Boulevard
Rockville, MD 20850
(301) 670-6700

Radisson Hotel Washington DC - Rockville
3 Research Center 
Rockville, MD 20850
(301) 840-0200

Cancellation
All cancellation requests must be submitted to raps@raps.org by 15 January 2019. 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 31 January 2019.  

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