Intermediate Course for Regulatory Submissions in eCTD Format (19 October 2017- 20 October 2017)

Registration closes at 11:59 pm Eastern, 10/16. If you need to register after this point, please email bbridges@raps.org.

Effective 5 May 2017 your company was required to migrate all NDAs, ANDAs and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. To ensure you have successfully met these new requirements, you 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 2017 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 to 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 two-day, hands-on compilation training that will answer your submission 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:

19 October 2017 (9:00 am–4:00 pm PDT), 20 October 2017 (9:00 am–3:00 pm PDT)

Meeting Location:

New Horizons Learning Center
7480 Miramar Road #202
San Diego, CA 92126

Registration Closes:

16 October 2017

Refund Deadline:

6 October 2017

RAC Credits:

10 

Will this meeting be recorded?

No

Proof of Attendance:

An electronic letter of attendance will be sent upon request.

Registration Fees:

Registration to 16 October 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 32 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 on the FDA electronic submission that became effective on 5 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

  • How to comply with the May 2017 electronic submission requirement
  • 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 for the US, Canada, and EU
    • Creating the initial sequence of an application
    • Assigning the metadata required by the regional authority and ICH
    • Lifecycling the application
  • Compiling will include:
    • Study Tagging (STFs)
    • Datasets
    • SPLs (Structured Product Labeling)
    • Granulated Clinical Study Reports (gCSR)
  • 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
  • The new Module 1 for marketing/advertising 2253 submissions 
  • Tips, tricks and best practices gathered from industry professional
  • Converting from a paper application to an eCTD application
  • What eCTD readiness really means

    NOTEProgram content may vary.  

    NOTE: The training facility will provide each student with computers for this program.

     

    Faculty

    Elsmari Eggers, head of training and RA consulting, LORENZ Life Sciences
    Nora Keeling, MS, 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: The training facility will provide each student with computers for this program. Attendees may bring their own laptops, but all exercises will take place on the computers supplied by the training center.

     

    Registration to 16 October 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 32 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: 6 October 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

    Bill Bridges
    bbridges@raps.org
    +1 301 770 2920, ext. 252 

    Area Airports
    San Diego International Airport (18 miles)

    Area Hotels
    The following hotels are located near the New Horizons Training Center:

    San Diego Marriott La Jolla
    4240 La Jolla Village Drive
    La Jolla, CA 92037
    Reservations: +1 858 587 1414

    Hyatt Regency La Jolla at Aventine
    3777 La Jolla Village Drive
    San Diego, CA 92122
    Reservations: +1 858 552 1234

    Holiday Inn Express & Suites San Diego–Sorrento Valley
    5925 Lusk Boulevard
    San Diego, CA 92121
    Reservations: +1 858 731 0100

     

    Cancellation

    All cancellation requests must be submitted to raps@raps.org by 15 September 2017. 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 October 2017

    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.