eCTD Submissions is part of the Knowledge & Networking Division of Informa PLC
This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.
eCTD Submissions
Practical solutions for managing regulatory requirements and new challenges
Dates, TBC
Venue TBC, Dubai, UAE
Call Me Back

"IIR Strikes again! Revolutionary concepts for those seeking radical change to ways of looking at business in today's information age. IIR great effort!"

Tariq Bashwari
Planning Analyst
Saudi Aramco

"This event provides the building blocks for becoming not only an effective worker, but also for developing into a genuine and sincere human being."

Cynthia Fernandes
Services and Travel Buyer
Masterfoods ME

"It is a life changing course that touches all aspects of one's life."

Mohammed Al-Fariss
Staff Projects Engineer

"An excellent course – adds real value to our experience."

Omar Jahameh
Finance Supervisor
Qatar Airways

".IIR is able to recognise and develop new trends. The delivery of innovative case studies adds tremendous value to conferences. This gives delegates the perfect balance between theory and practice. I believe in its formula."

Professor Robert Kaplan
Harvard University


More and more data is gathered and presented to support the quality, safety and efficacy of a drug. The quality and its consistency need to be assured during the entire product lifecycle to safeguard patients. Similarly, the benefit-risk ratio of the drug's usages need to be monitored and evaluated during the product's lifecycle. Hence, its supporting dossiers are subject to continuous change.

The eCTD allows for reflection of the product's lifecycle, with the documents that support the quality, safety and efficacy of a drug. But how does that eCTD lifecycle work? What is the impact on the document granularity and naming of documents? What do we mean by eCTD-ready documents? How do we create an eCTD? And what does a validation of an eCTD tell us? How can eCTDs for the same product be managed across multiple countries? These are all questions that will be addressed during this three-day workshop.

Course Content
  • Understand ICH CTD and eCTD guidelines
  • Understand regional eCTD requirements
  • Separate content from context to allow reusability and use it to define document granularity to support future lifecycle management
  • Preparing eCTD-ready documents
  • Compile and submit technically- and business-wise valid GCC eCTDs
  • Coping with business and technically invalid dossiers
  • Develop processes and procedures for managing eCTDs
  • Establish a company account
  • Future eSubmission development
Who Should Attend

This is a must-attend workshop for Regulatory Affairs professionals involved in submission procedures. The training will prove particularly helpful to those within the departments of documentation registration, dossier development, and electronic submissions.

The workshop will also benefit those within the pharmaceutical diaspora such as Publishing and Medical Writing, Senior Regulatory Affairs Scientists, Development & Quality Managers, Licence Compliance Officers, QA Pharmacist, Pharmacists, Senior Principle Statistical Programmers, Systems Managers, Certification Officers and Consultants.

Benefits Of Attending
  • Establish highly efficient processes to build, publish and deliver your regulatory submissions
  • Meet the challenges of managing eCTDs across multiple countries
  • Clarify regulatory ICH and local requirements
  • Identify criteria of technically valid business dossiers, and learn how to mitigate invalid dossiers
  • Consider future developments in the eCTD

    Hans van Bruggen

    Hans is a senior regulatory affairs specialist, with global experience in advising clients on the compilation and submission of electronic submissions and the preparation and maintenance of regulatory information. After gaining a BSc in Physiology Pharmacology, Hans began his career in drug safety R&D with NV Organon. After this, he moved on to work in positions in regulatory affairs and document management systems, including as eCTD subgroup leader for Efpia, leading the preparation of the EMEA guidance on paper dossiers based on eCTDs. In 2003, he was awarded a MSc in Pharmaceutical Medicine. Since 2007, he has led his own consultancy, Qdossier. Hans is an experienced trainer, delivering training courses in markets such as Europe, US and the Middle East. Hans is a regular contributor to conferences and symposia as a speaker and in the past has authored or coauthored multiple articles in academic journals.

    Dubai, UAE

    Dubai, United Arab Emirates

    Dubai is a luxurious city destination offering a contrast of east meets west, where the traditional and modern blend in harmony. Dubai is one of seven emirates that belong to the United Arab Emirates located in the Middle East.

    Some fast facts about Dubai, UAE

    • About 80 airlines land daily at the Dubai International Airport.
    • English is spoken quite fluently even though Arabic is the official language
    • Dubai has the largest free trade zone in the Middle East
    • The currency used is UAE Dirham which is pegged to the US Dollar
    • The time zone is GMT +4
    • Friday most businesses stay closed as it is the day of Friday prayers (Jumu'ah)
    • In 2016 Ramadan will take place in June

Date Course Fee Before
28 September 2017
Course Fee Before
3 November 2017
Final Fee
Dates, TBC
US$ 2,995 US$ 3,445 US$ 3,995

Course fees include documentation, luncheon and refreshments. Delegates who attend all sessions and successfully complete the course assessment will receive an Informa Certificate of Completion.

Pricing excludes 5% VAT, where applicable


Book and pay full fee for two colleagues and the third attends for FREE

  • Not applicable in conjunction with corporate discounts
  • Payment to be settled before start of the course to avail the offer
  • This offer is not applicable on Early Bird Prices

For more information, email Andy Watts on

You Might Want To Check These Related Events
Copyright © 2016. KNect365, All rights reserved