21-23 October 2025
Hotel Palace BerlinBerlin, DE21-23 October 2025
Hotel Palace Berlin,
Berlin, DE
Hotel Palace Berlin,
Berlin, DE
Your One-Stop Shop for Global eSubmission
ECTD V4.0. IDMP. EU-SRS. Regional Requirements. Get ready with updates from regulatory authorities and industry leaders.
Accelerate your eSubmissions and keep up to date with changes around the world
Global eSubmissions
- Understand the transition from paper to electronic submissions in emerging countries and how industry supports change with the Bayer
- Updates on electronic submissions in the Balkans and dive into country-specific environments with BIONIKA PHARMACEUTICALS
- Explore the regulatory changes ongoing in China, Taiwan, Japan and Thailand
Industry and Regulators Collaborations
- Hear from regulatory authorities during the European Regulators Forum on upcoming changes in submissions and data standards, including HMA/EMA Big Data Steering Group Co-Chair, Jesper Kjaer from the Danish Medicines Agency
- Accumulus Synergy 2022 Update: Find out how this cloud platform for sponsor-regulator data exchange is progressing from F.Hoffman-La Roche
- Review recommendations for eCTD implementation in countries considering adoption including examples from existing regions with GSK
Where IDMP and Regulatory Submissions Meet
- Explore how the submission of structured product data could impact the eCTD dossier process with ICH Taskforce member Dr. Andreas Franken, BAH
- How has the EMA’s DADI Project optimised submissions? Gain insight from project member Jen Klesh, Bristol Myers Squibb
- Medicines Evaluation Board and GSK reveal perspectives on the EMA’s IDMP based substance management system and forward considerations for data-sharing
Your eSubmissions Questions Answered
Connect with pioneers in the pharmaceutical regulatory landscape to help you:
