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PRE-EVENT WORKSHOP

eCTD submission in practice

Workshop Overview:

The electronic Common Technical Document (eCTD) was designed to make regulatory submissions easier and more efficient for regulators and drug manufacturers. It also contributed to harmonising and standardising drug approval practices across many regions and regulatory agencies. However, its implementation and usage is not without challenges. This workshop will give you an overview of what eCTD is, what its objectives are and it will provide you with practical tools to perform submissions in your organisation. The course is designed for regulatory affairs managers and for those in the pharma business looking to expand their knowledge of eCTD science and its submission process.

Workshop leader:

Jayaprakash Nallasamy
Domain and IT Solutions/Consultant - Regulatory and IDMP

Workshop Agenda:

09:30

Registration

10:00

Introduction of eCTD and its objectives

  • Paper-based submission CTD versus electronic-based submission eCTD: What are the advantages and disadvantages of both?
  • Introduction in the GCC countries - mapping who's using it and the regional differences
  • What is the goal of eCTD and how can it be useful for your organisation?
10:40

Morning refreshments

11:00

Mastering the eCTD format

  • Basic principles and structure: Backbone files, HTML and more
  • Defining the eCTD roadmap for emerging markets and the Middle East in particular
  • Assessing varying guidelines for submission content and formats in different countries
12:00

Case studies: Solving common implementation issues

Throughout various case studies, explore how eCTD was implemented in different organisations, find out about the common challenges and ways to overcome them

13:00

End of workshop

Workshop: 1 May 2017
Main Conference: 2 & 3 May 2017
Focus Day: 4 May 2017
The Address Dubai Marina, Dubai, UAE | #PharmaRegSummit
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