Presented by
Management Forum

Filing eCTD Submissions

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

20 Oct 2021 + 4 more dates

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  • Format: Live online, Classroom
  • 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.

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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

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Marloes van der Geer

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

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Maikel Bouman

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.



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Book Filing eCTD Submissions Live online/Classroom training

20 Oct 2021

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 11411

  • GBP 599
  • EUR 859
  • USD 970

In your basket 

18 Jan 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11115

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 14 Dec

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

25 Apr 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11612

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 21 Mar

In your basket 

11 Jul 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11888

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 06 Jun

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

19 Oct 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11733

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 14 Sep

In your basket 

Denmark

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

UK

  • Alliance Pharma plc and Alliance Pharmaceuticals Ltd
  • Jenson R+ Ltd
  • JensonR+ Ltd

Netherlands

  • EMA
  • European Medicines Agency

France

  • Veeva Systems

Israel

  • Gamida-cell

Switzerland

  • Vifor Pharma Switzerland

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Multiple colleagues?
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

+44 (0)20 7749 4749

inhouse@ipi.academy