Clinical Trial Regulation Information Day for CEE Countries Warsaw, Poland

This information day offers the unique opportunity for colleagues based in CEE region to join the discussion with key
regulators and industry experts on the preparedness status for the new legislation as well as associated
implementing acts in the region and how the new rules will impact clinical trials run in the EU in the future.

  • Key changes from Directive to Regulation and associated challenges
  • Procedure for Initial Authorisation and Substantial Modifications Mono and Multinational CTs and submission of the application dossier
  • Implementation and readiness status at the local level in Central and Easter European countries from competent authorities, Ethics Committees and industry perspectives
  • Update on the CT Information System (CTIS) formally “EU Portal and Database”
  • Clinical Trials Regulation related guidelines

Targeted audience
Regulatory agencies: assessors, reviewers, inspectors
The pharmaceutical industry and contract research organisations, including:
  • Regulatory affairs personnel in clinical research
  • Professionals in charge of clinical trial strategy
  • Regulatory intelligence and policy professionals
  • Change managers for clinical trials business processes
  • Clinical research professionals working with submission, data, information sharing
  • Clinical safety professionals