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Management Forum

Filing eCTD Submissions Training Course

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

16 Jan 2023
+ 3 more dates

Need help?  Enrol or reserve

  • Format: Live online
  • CPD: 6 hours for your records
  • Certificate of completion

Course overview

The eCTD (electronic Common Technical Document) is now mandatory for submissions in the EU and global regulatory agencies are also moving towards the eCTD as a standard submission process.

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission. The expert speakers will share their practical experiences of the eCTD and discuss how to implement efficient processes to build and publish submissions in both the EU and US. You will consider the eCTD validation criteria and how to prepare for these in your submissions as well as discuss life cycle management. An interactive case study session will explore eCTD submission challenges and logistics and help consolidate learning.

Benefits of attending:
  • Clarify the main components of the eCTD
  • Learn how to implement efficient processes to build, publish and deliver regulatory eCTD submissions
  • Discuss practical experiences of eCTD submissions in the EU and US
  • Consider life cycle management for eCTD submissions

Who should attend?

The course will be beneficial to regulatory professionals involved in the preparation of electronic submissions. It will also be of interest to anyone responsible for providing content for the eCTD or who wants to understand the eCTD better.

Enrol or reserve

The Filing eCTD Submissions course will cover:

Introduction and overview of the eCTD

  • The global regulatory framework

The benefits of using MS Word template

  • Demonstration of template

What are the main components of the eCTD?

  • Metadata
  • Documents
  • XML backbone

Life cycle management for eCTD submission

  • Granularity considerations
  • Combining documents
  • Use of operators

Review of eCTD validation criteria

  • Considerations (inherit zoom, filenames, node extensions etc)
  • How to prepare for these (to prevent validation issues)

Practical experiences of submitting eCTDs

  • Experiences submitting in EU
  • Experiences submitting in US

Live demo

Publish, compile and submit an eCTD sequence

Considerations for outsourcing

  • Why outsource eCTD vs in-house?
  • How to select the right eCTD partner
  • Best practices for an outsourcing process

Enrol or reserve

16 Jan 2023
24 Apr 2023
21 Jul 2023
17 Oct 2023

Maikel Bouman
Qdossier

Maikel Bouman works as a Senior Regulatory Operations Manager at Qdossier and in his role he has a strong focus on managing Regulatory Operations, coordination, and development of staff; planning and coordination of projects, including regulatory filings of dossiers across various regions and development and maintenance of technical solutions supporting Regulatory Operations. Maikel has a broad subject matter expertise on the quality control of data, document publishing, planning/coordination, management, preparation/creation and dispatch of different types of electronic submission formats to various regulatory authorities such as the United States, Canada, Europe, Australia and Switzerland.



More details

16 Jan 2023
17 Oct 2023

Mercia Lucouw
Qdossier

Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.
She provides regulatory support to a variety of pharmaceutical companies.

Mercia holds a bachelor degree in pharmacy (B.Pharm) from the North West University,
South Africa. For ten years she worked as a pharmacist in hospital and has routinely been
involved in international clinical trials. She is passionate to promote healthcare and recently
started her career in regulatory affairs. After joining Qdossier in 2021, she has been involved
several regulatory activities covering a variety of products.

Mercia’s areas of expertise are
preparation/creation and dispatch of different types of
electronic submission formats (e.g. US FDA, CA, EMA, CH)
, lean/structured authoring. She
is also part of the development team for Dosscriber™ (MS word eCTD document templates).

More details

24 Apr 2023
21 Jul 2023

Joanne Roza
Qdossier

Joanne Roza works as a senior regulatory affairs consultant at Qdossier. She is involved in regulatory affairs consultancy and has also expertise in regulatory operations for big- and small-sized pharmaceutical companies. Joanne holds a bachelor degree in Health Sciences from Maastricht University and a master degree in Health Economics, Policy and Law from the Erasmus University in Rotterdam. She started her career at Qdossier in 2016 and has been involved in a variety of regulatory operations and affairs projects. Joanne’s areas of expertise are: regulatory affairs (strategy and planning), preparation/creation and dispatch of different types of electronic submission formats (e.g. US FDA, CA, EMA, CH), lean/structured authoring and the creation of baseline (CMC) submissions.

More details

Book Filing eCTD Submissions Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

16 Jan 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12521

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 12 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

24 Apr 2023

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12122

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 20 Mar

View basket 

 
Not ready to book yet?

for 7 days, no obligation

21 Jul 2023

Live online

Course code 12719

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 16 Jun

View basket 

 
Not ready to book yet?

for 7 days, no obligation

17 Oct 2023

Live online

Course code 12387

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 12 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

United Kingdom

  • Alliance Pharma plc and Alliance Pharmaceuticals Ltd
  • Jenson R+ Ltd
  • JensonR+ Ltd
  • Kalvista Pharmaceuticals
  • McDonough Clinical Research Ltd
  • Subiaco Associates Ltd
  • Torbay & South Devon NHS Foundation Trust, trading as Torbay Pharmaceuticals

Denmark

  • Novo Nordisk Pharmatech
  • Novo Nordisk Pharmatech A/S
  • Oresund Pharma ApS

Netherlands

  • EMA
  • European Medicines Agency

France

  • Veeva Systems

Israel

  • Gamida-cell

Italy

  • SIFI S.p.A.

Korea, Republic Of

  • AJOU University

Spain

  • Faes Farma

Switzerland

  • Vifor Pharma Switzerland

Enrol or reserve

Run Filing eCTD Submissions Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy