Presented by
Management Forum
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"
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:This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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.
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.
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).
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
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
Until 21 Mar
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
Until 14 Jun
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
Until 28 Oct
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.
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
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
Director of Business Development, Celegence
United Kingdom
Denmark
Netherlands
Australia
France
Germany
Israel
Italy
Korea, Republic Of
Mexico
Spain
Switzerland
United States of America
1 day
Typical duration
Pricing from:
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: