Global eSubmissions 2014

Global eSubmissions 2014 is a conference dedicated to electronic submissions topics, including:

• EU telematics experiences including Common Repository, eSubmissions Roadmap, electronic Active Substance Master Files (eASMF), CESP
• EU regulatory agency expectations and requirements
• Regulatory operations insight and benchmarking
• Challenges faced by eSubmission archiving operations
• Global progress towards eSubmissions
• Complimentary evening discussion and networking session..
• How Novo Nordisk have developed effective strategies for eCTD only DCP and MRP submissions
• Changes and how to meet new expectations for eCTD Module 1 Submissions in the USA
• Implementation and use of Cloud publishing solutions

Who should Attend

Senior Managers, Heads, Publishers, Managers and specialists from pharma, biotech and generics companies involved in:

• Submissions
• Regulatory operations
• Regulatory affairs
• Publishing
• Dossier submissions & management
• Regulatory Information
• Document management