Learn the Tips to Speed Product Approval and Avoid Compliance Nightmares in Europe

We will be discussing the basic principles of the ICH eCTD submission standard as well as the overall picture of how the standard has been implemented by EMEA in terms of strategy, timelines, and submission procedure (Centralized vs Decentralized, Mutural Recognition and National Procedures.

Who Will Benefit

The Webinar will be valuable to any person working in Regulatory Affairs or Quality Management who are responsible for submitting to Europe or any other regulatory body.

Regulatory Affairs professionals
Quality Assurance professionals
CIO’s, CEO’s
Consultants

Background

On the 22 January 2008 the EMEA announced plans to accept from 1 July 2008, the electronic-only submission of information in support of marketing authorization applications (MAAs) under the CP: eCTD is the recommended electronic format. This will apply to all applications and all CP submission types in line with the rolling submission concept. This is a key announcement by the EMEA paving the way for the Electronic Common Technical Document (eCTD) as the exclusive, preferred standard for EU submissions.

This webcast is sponsored by TAKE Solutions, PharmaReady team.

Click Here to Regsiter or Contact us for more information.

What: Understanding EU Submissions Webcast

When: September 12, 2008
2–3 p.m. EST

Cost: Free

Register Now!

Click Here to Regsiter or Contact us for more information.