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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.

★★★★★ "Excellent webinar summarising the modular approach of eCTD and the differences between M1 for differ... more"

25 April 2024
+ 19 July 2024, 2 December 2024 »
from £549

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

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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

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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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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.

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Marloes van der Geer
Qdossier

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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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

25 April 2024

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 13600

GBP 549 649
EUR 789 929
USD 893 1,049

Until 21 Mar

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

19 July 2024

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 13816

GBP 549 649
EUR 789 929
USD 893 1,049

Until 14 Jun

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

2 December 2024

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 13945

GBP 549 649
EUR 789 929
USD 893 1,049

Until 28 Oct

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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.

Reviews of IPI's Filing eCTD Submissions training course

Excellent webinar summarising the modular approach of eCTD and the differences between M1 for different regions/countries. Found information on content versus context really important from a regulatory operations point of view and quality control aspects. Publishing eCTD readiness section also helpful - discussing components of headers/footers, redundant info, hyperlinking, appendices and cross referencing. Thoroughly enjoyed watching the live demo on building the submission in Docubridge, seeing the validation publish warning errors and backbone file explanations. Thank you very much indeed.

Jan 16 2023

Jillian Green United Kingdom
Assistant Regulatory Operations Manager, Kalvista Pharmaceuticals

Jan 16 2023

Great webinar, and showed that it worked for people that need a general understanding - whether new or not. Really engaging, great presentation and explanation. Pitched at the perfect level

Matt Tyler United Kingdom
Director of Business Development, Celegence

United Kingdom