European regulatory practice is moving fast toward data centric submissions and automation. That shift frames the Global Pharmaceutical Regulatory Affairs Summit 2026 which takes place 28 to 30 September in Berlin at Hotel Palace Berlin. The conference focuses on eSubmissions, regulatory data management and standards implementation such as IDMP and eCTD 4.0.
Dates and venue for Global Pharmaceutical Regulatory Affairs Summit 2026
The summit runs over three days from 28 to 30 September 2026 at Hotel Palace Berlin. Sessions cover ICH M4 evolution, CMC data transformation, modular eCTD strategies and practical AI applications for document intelligence. The speaker list includes senior figures from EMA and the European Commission and industry leaders from Pfizer, Moderna, Novartis and GSK. Notable speakers named in the agenda include Alessandra Leone, Jens Pantke and Ese Aziza.
Core themes and program shape
The program emphasizes the move from document centric submissions to data centric approaches and offers pragmatic tactics for implementing data quality specifications in CMC. Sessions examine how to align IDMP with SPQS, deploy modular approaches to eCTD for reuse, and incorporate real world data to strengthen regulatory packages. Practical AI cases show automated classification and intelligent extraction, alongside predictive frameworks to de-risk submission timelines.
Format includes expert led sessions, technical discussions and exchanges between regulators and data leads. Speakers from authorities and industry present implementation lessons and governance models, with contributions from figures such as Marcos Fernandez Gomez from the European Medicines Agency and Florian Schmidt from the European Commission.
Attendee profile and company types
Attendees are principally regulatory affairs leads, regulatory information management owners, data governance heads and vendors of submission platforms and compliance software. The audience mix is technical and strategic, composed of teams responsible for digital regulatory transformation and for aligning submissions with new legislative requirements.
How to prepare B2B outreach in Berlin
Set clear daily targets. Day one should focus on regulatory operations and data governance teams who are prioritizing master data management and lifecycle models. Day two is suited to eSubmissions owners where short demos of eCTD 4.0 interoperability and intelligent extraction add the most value. Day three is optimal for regulatory strategy leads to discuss impacts of evolving pharmaceutical legislation.
Practical materials to bring
- Short live demos showing integration with submission formats and data extraction.
- One page use cases on reducing manual effort in submissions.
- Technical briefs on IDMP and SPQS compatibility.
Schedule 20 minute meetings and follow up with references to sessions and speakers such as Vicki Cookson or Jörg Stüben to keep conversations technical and actionable.
Closing note and where to check details
For companies selling technology for automated submissions or regulatory data governance, the summit is a concentrated environment to validate product fit against current regulatory expectations. Check the full agenda and registration details on the official site at https://lifesciences.knect365.com/global-pharma-regulatory-affairs/ before finalizing meeting plans.
