22-24 October 2024
Sheraton Brussels Airport, Brussels,
Hybrid Event

Your One-Stop Shop for Global eSubmission

Accelerate your eSubmissions and keep up to date with changes around the world

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

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

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

Connect with pioneers in the pharmaceutical regulatory landscape to help you: