This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event
22-24 October 2024
Sheraton Brussels Airport, Brussels,
Hybrid Event

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:

Ensure Compliance with All Submission Types

Optimise Your Submission Processes

Keep in the Loop with Global Changes

Ensure Your System Matches with RIM

Successfully Prepare for eCTD v4.0

Learn How AI Can Help with Submission Management