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:
