EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza

• Date:
  Thursday, 05 June 2025, 13:00 - 17:00 Amsterdam time (CEST)
  Friday, 06 June 2025, 13:00 - 17:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

The workshop is organised to bring together academic, regulatory, industry and healthcare professionals.

It discusses similarities and major challenges experienced with the clinical study design in antiviral treatment trials for COVID-19 and influenza.

It also identifies and discusses feasible and clinically relevant primary efficacy endpoints that can generate robust data to allow the approval of new antivirals or monoclonal antibodies for the treatment of COVID-19 and influenza.

In addition, the workshop sheds light on different aspects on pandemic preparedness. These include:

• clinical study designs,
• the importance of pre-approved protocol for clinical trials that can be implemented during a pandemic,
• evidence needed to support public health recommendations and stockpiling of antivirals and monoclonal antibodies.

Documents

Agenda - EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended to treat COVID-19 and Influenza

Draft

Video recordings

The recordings and slides for the presentations given during the workshop are available below.

Day 1

Day 2