Le Lézard
Classified in: Science and technology
Subjects: TRD, MRR

Filing eCTD (electronic Common Technical Document) Submissions Training Course: Now Mandatory for Submissions in the EU and Global regulatory Agencies


DUBLIN, Aug. 25, 2023 /PRNewswire/ -- The "Filing eCTD Submissions Training Course" conference has been added to ResearchAndMarkets.com's offering.

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This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for 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 the 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.

Who Should Attend:

The course will be beneficial to regulatory professionals involved in the preparation of electronic submissions. It will also be of interest to anyone responsible for providing content for the eCTD or who wants to understand the eCTD better.

Benefits of attending:

Key Topics Covered:

Introduction and Overview of the eCTD

The benefits of using MS Word template

What are the main components of the eCTD?

Life cycle management for eCTD submission

Review of eCTD validation criteria

Practical experiences of submitting eCTDs

Live Demo

Considerations for outsourcing

Speakers:

Maikel Bouman
Senior Regulatory Operations Manager
Qdossier

Maikel Bouman works as a Senior Regulatory Operations Manager at Qdossier and in his role he has a strong focus on managing Regulatory Operations, coordination, and development of staff; planning and coordination of projects, including regulatory filings of dossiers across various regions and development and maintenance of technical solutions supporting Regulatory Operations. 

Maikel has a broad subject matter expertise on the quality control of data, document publishing, planning/coordination, management, preparation/creation and dispatch of different types of electronic submission formats to various regulatory authorities such as the United States, Canada, Europe, Australia and Switzerland.

Mercia Lucouw
Celegence

Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.

She provides regulatory support to a variety of pharmaceutical companies.

Mercia holds a bachelor degree in pharmacy (B.Pharm) from the North West University, South Africa. For ten years she worked as a pharmacist in hospital and has routinely been involved in international clinical trials. She is passionate to promote healthcare and recently started her career in regulatory affairs. After joining Qdossier in 2021, she has been involved several regulatory activities covering a variety of products.

Mercia's areas of expertise are preparation/creation and dispatch of different types of electronic submission formats (e.g. US FDA, CA, EMA, CH), lean/structured authoring. She is also part of the development team for DosscriberT (MS word eCTD document templates).

For more information about this conference visit https://www.researchandmarkets.com/r/12dgyv

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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SOURCE Research and Markets


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