10 Small Submissions
No more than 10 Documents per submission
SOUTH AFRICA, AUSTRALIA, MIDDLE EAST, THAILAND
Freyr is pleased to present a free webinar featuring “eCTD Roadmap For Emerging Markets”.
The webinar’s focussed approach makes it a must-attend for all sponsors and Regulatory professionals involved with eCTD to impart insights about preparing to submit the dossier in eCTD format especially in South Africa, Australia, Middle East and Thailand.
In this webinar, Freyr’s industry experts examine the underlying issues faced by Life Science companies as they encounter new global regulatory challenges while making regulatory submissions in the electronic Common Technical Document (eCTD) format. Companies can prepare their regulatory eCTD strategies in-line with country specific requirements/mandates (ICH guidelines). It also offers a thorough understanding and use of templates, tools and best practices irrespective of the eCTD building and publishing tool used.
Discussion Topics Covered During The eCTD Webinar
- Basic concepts – eCTD publishing
- Identification of components
- Lifecycle management concepts
- Publishing challenges in upcoming regions
- Outlining process and tools
- Suggestions for bookmarking and hyperlinking
- Impact assessment
Who Should Attend the eCTD Webinar?
The webinar is highly recommended for all middle and top level global regulatory professionals involved in:
- Document management
- Electronic regulatory submissions
- Medical/Labeling/Scientific writing
- Project management
- Regulatory Operations
- Regulatory affairs
Benefits of attending the eCTD webinar
The eCTD webinar offers an ideal opportunity for learning the very latest regulatory
electronic compliance information for emerging markets. It also covers the standards, groundwork, expertise and technology required to submit compliant electronic submissions. The webinar will offer the following benefits:
- Describe basic concept of eCTD publishing in various countries
- Identify components that comprise an eCTD submission
- Discuss lifecycle management concepts for an eCTD submission
- Explain publishing challenges of eCTD submissions in upcoming regions –
South Africa, Australia, Middle East and Thailand - Outline process and tools needed to compile and manage an eCTD and switch
from Paper/ NeeS to eCTD - Suggestions for bookmarking and hyperlinking within and across documents
- Assess impact on the authoring environment (content reuse)
At the conclusion of the webinar, participants will have a comprehensive overview of eCTD including the basics and terminology to rules and regional standards to submission output and solutions in emerging markets, and more.
