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01-12-2020 (Live Online)

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Live Online: eCTD and eSubmission Masterclass

1 – 4 December 2020 | 4-Day Live Online | 1:30 pm – 5:30 pm (SGT)

Book Now Register Your Interest Download Brochure

Early Bird Rate: Register & Pay by 2 October 2020
Register 2 Delegates & the 3rd attends FREE!

overview

About The Course

The process of developing & submitting a regulatory submission for approval is complex requires significant amount of data to be collated. As global regulatory agencies accelerate the implementation ICH eCTD format, regulatory affairs compliance, data and dossier management teams require up to date knowledge of the latest regulations and trends, as well as competencies in the process of writing and building documents.

This masterclass enables pharmaceutical companies to assess and address their readiness for eCTD across people, process and tools perspectives. Upon attending, you will understand how to apply to your ICH and regional requirements, QC & validation criteria to your eCTD; as well as how to organise applications in the correct electronic format and style ready for submission.

 

Key Learning Outcomes

  • Latest development on regulatory agencies’ guidelines on eSubmissions and ICH eCTD format
  • eCTD submission reviews for both agencies and applicants
  • Applying ICH and regional requirements to your eCTD
  • Quality control and validation criteria in eCTD
  • Address organisational process to achieve eCTD readiness
  • Preparing for your eSubmissions: Common pitfalls and how to avoid
  • Developing effective eCTD lifecycle management
  • Managing an eCTD lifecycle through multiple agencies
  • Practical exercise: Building and submitting an eCTD

pricing

Packages Price
Live Online LearningSGD $2876

Early Bird Rate: Register & Pay by 2 October 2020

Register Group of 10 for SGD $12,950

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate only.
For Group Registrations, email register@informa.com or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organization registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Course Director

Daria Wain
Regulatory Publishing Specialist & Trainer
Pharma to Market Pty Ltd

view profile »

Live Online Learning

Stay Home. Skill Up!

The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.

To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.

Benefits of Live Online Learning

Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.

  • Classroom Experience: Progress with fellow participants as you would in an on-site class
  • Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
  • Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
  • Module-based approach to effectively manage your time and revisions
  • Earn your Digital Certification and broadcast your achievements to your peers
  • Onboarding: Available for all attendees
  • Proven and secure training platform

 

Click here to know more >

Digital Badge

Upon completion of this training course, participants will earn a digital badge.

Eligibility:
Attend and participate in the full training course duration, led by the designated training expert

Available to:
Seminar attendees

Digital Badge FAQ >

Agenda

Impact of the eCTD on the regulatory submission process

  • Introduction – from CTD to eCTD, electronically from applicant to agency
  • Key challenges in using eCTD
  • eCTD validation and review process
  • eCTD submission review for both agency and applicant
  • Organising your eCTD – Options for structure and design
  • Tracking the progress and success of eCTD around the world
  • Reusability of eCTDs across regions
  • Exemption and waiver to eCTD requirements

 

Preparing for eCTD

  • Transforming documents into electronic dossier
  • Creating eCTD
  • Common pitfalls and how to avoid them

 

eCTD structure:

  • region-specific administrative information
  • manufacturing, nonclinical, and clinical overviews and summaries
  • detailed manufacturing information
  • nonclinical study reports
  • clinical study reports

 

Harmonised procedures in the US/EU/Asia

  • Overview of electronic submission across regions
  • Evaluating the challenges towards technical harmonisation
  • Agencies’ eSubmission roadmap
  • Online submissions – through gateways and portals

 

Practical Exercise – Lifecycle management

  • Effective eCTD lifecycle management
    • eCTD lifecycle operators
    • eCTD lifecycle challenges and management
    • Validation
  • Tracking and reporting on how previously submitted documents are affected by variations and amendments.
  • Maintaining control of an evolving dossier
  • Ensuring you capture all lifecycle documents, including responses to questions, variations/amendments and Renewals
  • Managing document obsolescence efficiently
  • Managing an eCTD lifecycle through single or multiple agencies

 

Case Studies:

  • Generic and biologic drugs
  • Combination drugs

 

Building & submitting eCTD

  • Applications Tools required in submitting electronically
  • eCTD creation and assembly
    • Creating file/folder structure and assigning documents
    • Hyperlinks and eCTD attributes
    • Building the required XML backbone and regional XML

 

Regulatory requirements for product lifecycle

  • Time management and project planning for eSubmissions

 

Practical exercise

  • eSubmission Strategy and eSubmission project management
  • What is XML and where is it used in the eCTD?
  • Understanding the general concepts, terms and “Util” directory
  • Building the required XML backbone and regional XML
  • Hyperlinks and eCTD attributes

when & where

01 - 04 Dec 2020

4-Day Live Online
1:30 pm – 5:30 pm (SGT)

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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