eCTD and NeeS Take Centre Stage at ISI Sentinel Webinar
- Comprehensive session on April 7th, featuring first-hand experience from the Medical Products Agency (MPA) in Sweden, will help life sciences organisations choose their own optimum path to electronic submissions, as European Medicines Agency requirements tighten
Eschborn, Germany – March 30, 2010 Image Solutions Inc. (ISI), a leading provider of electronic submissions management and publishing solutions for the life sciences community, is to host a special electronic submissions webinar on April 7th, featuring Karin Gröndahl, Head of Registration and Information Management at the Medical Products Agency (MPA) in Sweden and ISI’s Kate Wilber, Director of ISI’s European Regulatory Services group. The complimentary session will provide critical information to help ease the transition of pharma organisations to electronic submissions, in both electronic common technical document (eCTD) and non-eCTD electronic submissions (NeeS) formats.
Webinar Overview
The European Medicines Agency is moving rapidly toward being a fully electronic environment for regulatory submissions. While the emphasis ultimately is on the eCTD standard, there is growing support from EU regulatory leaders for a broader approach that encompasses non-eCTD electronic submissions. With insights from an electronic-only champion at Sweden’s Medical Products Agency (MPA) and a leading expert on managing electronic product submissions, ISI’s penetrating webinar, eCTD and NeeS Take Centre Stage, explores the opportunities for creating a paperless environment with eCTD as the dominant format and NeeS as the format of choice for older National Procedure submissions.
Why attend?
The eCTD and NeeS Take Centre Stage webinar will cover:
- Opportunities presented by the release of the NeeS validation criteria, how those criteria have helped clarify and streamline the format, what this means for companies and regulators, and efforts to drive toward a paperless environment within the EU;
- Specifics about where and when to apply NeeS versus the eCTD and how many submissions have been received to date;
- The impact of the filing procedure on the submission format in the EU, and planning strategically in order to make the most of an environment that promises enhanced reviewing processes, reduced administrative and logistical responsibilities – and, above all, the ability to ensure a speedier and more thorough process.
Session details
The eCTD and NeeS Take Centre Stage webinar will take place on Wednesday April 7th at 14.30 GMT / 15.30 CET
Full details of the webinar as well as registration information can be found at: http://events.imagesolutions.com/SentineleCTDandNeeS