DUBLIN, Aug. 25, 2023 /PRNewswire/ — The “Filing eCTD Submissions Training Course” conference has been added to ResearchAndMarkets.com’s offering.
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:
- Clarify the main components of the eCTD
- Learn how to implement efficient processes to build, publish and deliver regulatory eCTD submissions
- Discuss practical experiences of eCTD submissions in the EU and US
- Consider life cycle management for eCTD submissions
Key Topics Covered:
Introduction and Overview of the eCTD
- The global regulatory framework
The benefits of using MS Word template
- Demonstration of template
What are the main components of the eCTD?
- Metadata
- Documents
- XML backbone
Life cycle management for eCTD submission
- Granularity considerations
- Combining documents
- Use of operators
Review of eCTD validation criteria
- Considerations (inherit zoom, filenames, node extensions etc)
- How to prepare for these (to prevent validation issues)
Practical experiences of submitting eCTDs
- Experiences submitting in the EU
- Experiences submitting in the US
Live Demo
- Publish, compile and submit an eCTD sequence
Considerations for outsourcing
- Why outsource eCTD vs in-house?
- How to select the right eCTD partner
- Best practices for an outsourcing process
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
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