-

1-Day Filing eCTD Submissions Course: London, United Kingdom - April 6th, 2020 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Filing eCTD Submissions" conference has been added to ResearchAndMarkets.com's offering.

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

Agenda

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 the 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

For more information about this conference visit https://www.researchandmarkets.com/r/9wzi0c

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Industry:

Research and Markets

Release Versions
English

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

More News From Research and Markets

1 Day Clinical Trial Agreements Training Course: Key Legal, Regulatory and IP (Intellectual Property) Considerations for the EU (European Union) and UK Markets (Mar 18, 2026) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Clinical Trial Agreements: Key Legal, Regulatory and IP (Intellectual Property) Considerations for the EU (European Union) and UK Markets Training Course (Mar 18, 2026)" training has been added to ResearchAndMarkets.com's offering. The life sciences sector is heavily regulated and CTAs are some of the most important agreements for companies operating in this sector. Having appropriate CTAs in place is therefore essential for managing relationships between the diffe...

Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd - Mar 3rd, 2026) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd - Mar 3rd, 2026)" training has been added to ResearchAndMarkets.com's offering. Understand the regulatory frameworks governing drug/device and device/drug combinations in the European Union and the USA. The demarcation between medicinal products and devices is becoming ever more important and, with the conve...

Wedding Rings Market Trends, Shares and Growth Prospects 2025-2030 - Cultural and Social Trends Around Minimalism and Modern Design Drive Adoption of Non-Traditional Styles - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Wedding Rings - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering. The global market for Wedding Rings was valued at US$56.7 Billion in 2024 and is projected to reach US$80.7 Billion by 2030, growing at a CAGR of 6.1% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The wedding ring market is expanding due to a combin...
Back to Newsroom