• CTIS (Clinical Trials Information System) domestic and international experiences
  • Deadlines for authorization of “single country” submissions (experiences and results so far)
  • Practical experiences and questions related to the conclusion of clinical trial contracts in Hungarian state-run institutions
  • The impact of the changing situation of institutional pharmacies on clinical trials
  • EMA EMR guideline (Guideline on computerized systems and electronic data in clinical trials) expectations and domestic compliance options
  • The effects of clinical trials on the national economy, as well as their assessment possibilities
  • Prerequisites for MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostics Regulation) clinical trials
  • Duties of Qualified Person in medical device development processes

https://www.altagra.hu/mkvt2024/