Management Forum Logo

Presented by
Management Forum

Filing eCTD Submissions In-house Training

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"

Need help?  Customise

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.

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
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

  • Alliance Pharma plc and Alliance Pharmaceuticals Ltd
  • Broughton Life Sciences
  • Celegence
  • Jenson R+ Ltd
  • JensonR+ Ltd
  • Kalvista Pharmaceuticals
  • McDonough Clinical Research Ltd
  • Red Line Pharmacovigilance Ltd
  • Rosemont Pharmaceuticals 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

Australia

  • Biopharm Australia

France

  • Veeva Systems

Germany

  • INFECTOPHARM Arzneimittel und Consilium GmbH

Israel

  • Gamida-cell

Italy

  • SIFI S.p.A.

Korea, Republic Of

  • AJOU University

Mexico

  • Zeyco

Spain

  • Faes Farma

Switzerland

  • Vifor Pharma Switzerland

United States of America

  • Celegence

Run Filing eCTD Submissions Bespoke training for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee, based on 10 attendees
  • 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

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy