Delivering the latest on global progress towards eCTD, EU telematics and industry benchmarking for eSubmission process optimisation.
What is New for 2015?
- Focus on new global regions exploring latest developments and progress on eCTD in the Gulf Coast Council (GCC), Oman, Thailand and the US
- Direct feedback from the Medicines Control Council on the eCTD pilot project in South Africa
- Practical industry case studies into submissions process optimisation followed by an interactive evening experience exchange
- Understand the new PSUR repository and the implications for industry submission teams
- Examine the implications of the new EU Clinical Trial Regulation (Regulation No 536/2014) on submissions and publishing teams