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eCTD Submissions
Practical solutions for managing regulatory requirements and new challenges
5 – 7 December 2017
Kempinski Hotel, Mall of the Emirates, Dubai, UAE
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Overview

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.



    Kempinski Hotel, Mall of the Emirates

    Dubai, United Arab Emirates


    Kempinski Hotel Mall of the Emirates

    Celebrate the 10 year anniversary of Kempinski Hotel Mall of the Emirates which is connected to the award winning Mall of the Emirates, retailing 560 prestigious brands, a 24 screen multiplex cinema and the region's largest indoor ski slope and snow park.

    With 393 rooms and suites, including 20 stunning Aspen Chalets, we boast some of the most unique and modern accommodations. All rooms are well equipped with the state of the art technology for your comfort.

    A destination guaranteed to create memorable moments for business or leisure travelers; we welcome you to a five star luxury retreat.


    Kempinski Hotel Mall of the Emirates Dubai
    Sheikh Zayed Road, Al Barsha
    P.O. Box 120679
    Dubai, United Arab Emirates

    Tel +971 4 341 0000
    Fax +971 4 341 2327

    https://www.kempinski.com/en/dubai/mall-of-the-emirates

    Accommodation

    Special delegate rates have been negotiated at selected hotels and we highly recommend you secure your room reservation at the earliest to avoid last minute inconvenience. You can contact the Hospitality Desk for required assistance on:

    T:+971-4-407 2693
    F:+971-4-407 2517
    E: hospitality@informa.com


    VISAS

    Delegates requiring visas should contact the hotel they wish to stay at directly, as soon as possible. Visas for non-GCC nationals may take several weeks to process.


Date Course Fee Before
28 September 2017
Course Fee Before
3 November 2017
Final Fee
5 – 7 December 2017
(BC6943)
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.

*

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 a.watts@informa.com

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