10th Annual Global eCTD Management

Informa Life Sciences 10th Annual Global eCTD Management conference brings together more regulatory agency and industry speakers than any other electronic submissions conference in Europe.

Conference Highlights

Hear the latest progress on EU telematics initiatives, including

EU eSubmissions Roadmap, EMA Gateway, CESP, eAF and eSignatures

Gain first hand regulatory feedback, advice and updates from 7 EU and international regulatory agencies

Saudi FDA (Saudi Arabia), MHRA (UK), BfArM (Germany), Fimea (Finland), SUKL (Slovakia), DHMA (Denmark) andANSM (France)

Understand the changes and ensure compliance

under the new eCTD validation criteria v5.0 and NeeS validation criteria v4.0

Discover the state of cloud computing solutions

and their suitability for regulatory publishing teams

Gain regulatory feedback and advice

on eSubmission archiving from Fimea

Find out how eCTD is being globalised and the current status in

Saudi Arabia, ASEAN, Australia and South Africa

Benefit from enhanced networking and experience sharing opportunities

with 3 new interactive sessions: The Experience Exchange, The Top Table Panel & the EU Telematics World Café

Practical case study insight

into the conversion of legacy dossiers to eCTD, supporting emerging market submissions and managing international operations teams

Benchmarking opportunities

including efficient MRP and DCP submission strategies

Speaker and Presenter Information

Miguel Bley - European Affairs Coordinator, ANSM Klaus Menges - Director, Federal Institute of Drugs and Medical Devices (BfArM) Elke Schydlo - Global Head Submission & Registration Management & Data Analytics, Abbott Laboratories GmbH Andreas Franken - Head of Clinical Research, Manager eSubmission, German Medicines Manufacturers Association (BAH) And Many More!