Preparation of Product Dossiers in eCTD and NeeS Formats
Organization: IPA, An AAPS Company
Venue: Dorint Don Giovanni Praha
|Event Date/Time: Mar 18, 2013||End Date/Time: Mar 20, 2013|
The regulatory professionals are central to the business of pharmaceutical development, not only as the primary communicator with health authorities, but also as the one responsible for communicating regulatory concerns and opportunities across all the functions represented on a development team. For regulatory professionals to deliver this communication leadership, they need to see their unique position within the company, accept the need for a wide variety of advanced communication skills, and establish ways to develop them.
One of the critical area of any regulatory professional is having sound expertise in the area of regulatory submission and being able to meet the Health Authorities ever demanding requirements.
While eCTD is the way forward however, majority of the developed and developing nations still support paper submissions as opposed to electronic submissions until they are equipped to fully accommodate electronic submissions.
Furthermore, as of January 2010, the European Medicines Agency (EMA) will no longer accept NeeS as a method of submission and all eSubmissions must be eCTD format.
This interactive training and workshops will cover in detail all the requirements on Electronic submissions (NeeS and eCTD) and paper documentation.
This program has been customized to demonstrate a general understanding of the eCTD, its components and history, preparing submission ready documents, as well as best practices for changing your business processes in preparation for moving towards electronic submissions.
Other areas of this training workshops include also includes evaluating the impact of various regional interpretations of eCTD specifications and guidelines on global submissions strategy. Participants will then apply this information and compile example submission for a single country of EU national and US FDA.
At the conclusion of this course, participants should be able to:
- Demonstrate a general understanding of the CTD, eCTD, and Nees
- Understand the requirements and concepts of the eCTD
- Compile a technically validated eCTD for various regions
- Explain how to maximize the re-use of compiled content
- Describe the eCTD publishing and technical validation