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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.

Details

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.

Programme

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

Presenters

Marloes van der Geer (More...)

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).

Maikel Bouman (More...)

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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NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
19 Oct 2022
Live webinar
09:30-17:00
UK (London)
19 Oct 2022
Live webinar
09:30-17:00
UK (London)
GBP 599 499
EUR 859 719
USD 970 814
Until 14 Sep*
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

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  • Faes Farma
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  • McDonough Clinical Research Ltd
  • Novo Nordisk Pharmatech
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  • Torbay & South Devon NHS Foundation Trust, trading as Torbay Pharmaceuticals
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