Intermediate Course for DMF, ASMF, Module 3 Submissions in eCTD Format - Frankfurt

If you are currently preparing and maintaining paper ASMFs and DMFs and/or Module 3 in eCTD for the EU, US, Canada and/or Switzerland and have to use the eCTD format, this course is for you.

The FDA’s May 2018 deadline mandates that you comply with the new requirements. The use of eCTD is already mandatory for all for centralised procedure human ASMF submissions from 1 July 2016. To successfully meet these 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:

  • How structured and transparent the eCTD lifecycle of an ASMF/DMF can be, for
    • EU (including an Applicant’s and Restricted Part)
    • US
    • Canada
    • Switzerland (including an Applicant’s and Restricted Part)
  • What Module 1 documents need to be added
  • What the routing is of questions and responses
  • How structured and transparent the Module 32S and 32P for an applicant are
  • How easy eCTDs can be created and maintained
  • How to set up gateways with authorities
  • How quick eCTDs can be exchanged with the authorities
  • How to create a baseline submission
  • How to apply lean authoring principles
  • How to QC and validate an eCTD
  • Tips, tricks and best practices gathered from industry professionals
  • Converting from a paper application to an eCTD
  • What CTD readiness really means

We will also provide an overview of the difference between submissions to US, EU, Canada and Switzerland and help you understand how to prepare for each.

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.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Faculty
  • Registration Info
  • Cancellation

At a Glance

Date:

6–7 November 2017 (09:00–16:30)

Meeting Location:

Frankfurt Holiday Inn—Alte Oper
Mainzer Landstraße 27
DE-60329
Frankfurt am Main
Germany

Registration Closes:

1 November 2017

Refund Deadline:

7 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:

(All fees in US dollars. Euro equivalents are shown for reference only, and are subject to exchange rate at time of registration.)

 

Registration to 7 October 2017
RAPS Members:  $1,350 (approx. €1,205)

List:  $1,450 (approx. €1,295)

 

Registration from 8 October to 1 November 2017
RAPS Members:  $1,450 (approx. €1,295)

List:  $1,550 (approx. €1,385)

 

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 40 people

Objectives

After listening to presentations and completing class activities, participants will be able to:

  • Identify best practices with software used to generate and maintain ASMFs/DMFs in eCTD format
  • Define the acronyms and terms surrounding eCTD and electronic submissions
  • Apply ICH and regional requirements for eCTD-readiness of documents
  • Set up gateways with authorities
  • Describe 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 ASMFs, DMFs and Module 3 documents in general. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to meet the existing requirements for EU, Canadian and Swiss submissions and the FDA electronic submission deadlines in May 2018.

This workshop is beneficial for professionals working in the APIs, containers, excipients, and finished product fields who are involved in the preparation of electronic submissions, particularly technical writers, regulatory operations and regulatory affairs.

Agenda

  • How are the ASMFs/DMFs used by the Health Authorities
  • What are the regional differences for the ASMF and DMF for the DMF holder?
  • What are the regional differences for the ASMF and DMF for the applicant?
  • How to structure Module 3.2.S for chemical entities
  • How to structure an ASMF for APIs in the EU and Switzerland
  • How to structure a DMF for APIs, Intermediates, Excipients, Container Closure Materials and Finished Product for the US and Canada
  • How to structure Module 3 for the applicants of chemical entities and its finished medicinal products.
  • How to set up eSubmission gateways in the US, EU, Canada, and Switzerland
  • How to validate and interpret validation reports
  • Best practices in MS Word and Adobe Acrobat to generate compliant PDF files
  • Hands-on compilation of an eCTD
    • Module 1 differences for the US, Canada, and EU
    • Assigning the metadata required by the regional by the regional authority and ICH
  • Module 3 for:
    • ASMF applicant’s part
    • ASMF restricted part
    • Applicant’s Module 3.2.S
    • DMF for:
      • API
      • Intermediate
      • Finished Product
      • Excipient
      • Container Closure System or system part
    • 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

Maikel Bouman, regulatory operations manager, Qdossier B.V.
Elsmari Eggers, head of training and RA consulting, LORENZ Life Sciences
Hans van Bruggen, director, Qdossier B.V.

Registration Info

IMPORTANT: Attendees must bring their own laptops and power adaptors. RAPS does not provide equipment for attendees. 

(All fees in US dollars. Euro equivalents are shown for reference only, and are subject to exchange rate at time of registration.)

Registration to 7 October 2017
RAPS Members:  $1,350 (approx. €1,205)
List:  $1,450 (approx. €1,295)

Registration from 8 October to 1 November 2017
RAPS Members:  $1,450 (approx. €1,295)
List:  $1,550 (approx. €1,385)

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 40 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: 7 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 

Logistics Contact 

Wessel Nieuwenweg  
wessel@newway-management.com  
+33 9 67 62 61 04  

Area Airports 
Frankfurt am Main Flughafen (Airport) is 14 kilometers from the hotel.  ICE trains from the train station are available to Frankfurt Central Station, from the Central station to hotel is a six minute walk.  For maps and detailed instructions click here.

Driving Directions
Coming from A5: Turn onto A5. Take exit 19-Westkreuz Frankfurt and follow the A648/F-Stadtmitte. Keep on Theodor-Heuss-Allee/B44/B8. Turn right into the Friedrich-Ebert-Anlage/B44 and afterwards into Mainzer Landstrasse. 

Coming from A3: Turn onto A3. Take the exit 51-Flughafen Frankfurt-Frankfurt-Süd and follow the B43 in direction F-Süd/F-Stadtmitte. Keep driving on Stresemannallee/B44. Turn right into Karlstraße and afterwards into Mainzer Landstraße. 

Parking
Limited parking is available at the hotel at a fee of approximately €25 per day.

Taxi
Making use of a taxi service is a convenient way to travel to Frankfurt’s city centre. Traveling from Frankfurt Airport to downtown Frankfurt via taxi will take 20–30 minutes, provided that traffic conditions are reasonable, and will cost approximately €25. Frankfurt taxis are readily available outside both terminals of Frankfurt Airport. Taxi fares are metered, therefore the further your destination, the higher the fares will be. In some cases, the taxi drivers may take an unnecessarily long route in order to increase the fares. Unfortunately, this is hard to avoid if you are not familiar with the city and we therefore recommend using the official Frankfurt Airport taxi cabs online. 

Hotel Accommodation
RAPS has secured a discounted room block at the Frankfurt Holiday Inn for class attendees. To receive the discounted rate, bookings must be made by registering through the following link: RAPS 06NOV17. Please indicate that you are participating in the RAPS workshop on 6–7 Nov. 

Check-in time is 15:00. Although the hotel will make every reasonable effort to accommodate guests who arrive before the check-in time, the client recognizes that guest rooms may not be immediately available. Baggage storage will be available. The hotel check-out time is 12:00 on the day of departure. 

Room Rate: between €129 – 169 per night (including tax)

Room Rate Includes:

  • Complimentary breakfast buffet
  • Free WiFi internet for all in house guests

 

Cancellation

All cancellation requests must be submitted to raps@raps.org by 7 October 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 23 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.