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.

6 Apr 2020

& 6 Oct 2020

GBP 699
EUR 979
USD 1,090

Book now

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
What are the main components of the eCTD?
  • Metadata
  • Documents
  • XML backbone

Implementing efficient processes to build, publish and deliver regulatory eCTD submissions

The benefits of using MS Word template
  • Demonstration of template
Considerations for outsourcing
  • Why outsource eCTD vs in-house?
  • How to select the right eCTD partner
  • Best practices for an outsourcing process
Practical experiences of submitting eCTDs
  • Experiences submitting in EU
  • Experiences submitting in US
Case study – eCTD submission challenges and logistics
  • Recent client MAA
  • Metadata
  • Life cycle considerations for client
Review of eCTD validation criteria
  • Considerations (inherit zoom, filenames, node extensions etc)
  • How to prepare for these (to prevent validation issues)
Life cycle management for eCTD submission
  • Granularity considerations
  • Combining documents
  • Use of operators

Key points to take away for successful eCTD submission

Presenters

Jasbir Chohan (6 Apr 2020, 6 Oct 2020)

Jasbir Chohan is the Founder and CEO of ONIX and has over 19 years in the pharmaceutical industry. Jasbir started the company in 2010 and has established a worldwide customer base. In 2013, Jasbir was selected for the Business Management Programme Scholarship by University of College London (UCL) and Goldman Sachs for 10K Small Business. Jasbir has a vast knowledge of eCTD Global Regulatory Operations Requirements and has worked in Industry until transitioning to Consultancy in 2007. She is regularly invited as a key speaker at educational training programmes and conferences. Jasbir specialises in supporting companies looking to develop or transition their regulatory operations to an eCTD compliant infrastructure, alongside this she provides an oversight for PDF publishing, eCTD compilation tasks and quality assurance compliancy for electronic submission procedures and processes

Justin Bailey (6 Apr 2020)

Justin is a Senior Consultant at ONIX and has worked within the industry for over 11 years. He has a background in Submission Management, working for pharmaceutical companies and a Regulatory Operations software vendor. Justin provides ONIX clients with consultancy advice and project management on global eCTD regulatory operation requirements. Justin is experienced in all aspects of e-submission publishing and oversees the management of eCTD submissions to health authorities and life-cycle management

Book now

6 Apr 2020
6 Apr 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
6 Oct 2020
6 Oct 2020 Rembrandt Hotel, London
+ VAT @ 20.00%
Enrol now