Topics
- Regulatory feedback, advice and updates from 7 EU and international regulatory agencies
- EU telematics initiatives, including EMA Gateway, EU eSubmissions Roadmap, eAF, CESP and eSignatures
- The state of cloud computing solutions and their suitability for regulatory publishing teams
- The new eCTD validation criteria v5.0 and NeeS validation criteria v4.0
- How eCTD is being globalised and the current status in
- Regulatory feedback and advice on eSubmission archiving from Fimea
- Practical case study insight into the conversion of legacy dossiers to eCTD, supporting emerging market submissions and managing international operations teams
- Saudi Arabia, ASEAN, Australia and South Africa
- Benchmarking opportunities including efficient MRP and DCP submission strategies
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
eCTD - Electronic Common Technical Document
