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
