13th Industry Standing Group (ISG) meeting

• Date:
  Monday, 30 June 2025 , 09:00 - 13:15 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The Industry Standing Group (ISG) is a forum for interaction that has been established as part of the EMA's continuous improvement for engagement with industry stakeholders supply chain of human, veterinary and medical device sectors on activities within EMA’s responsibilities.

It aims to facilitate regular exchange of views and promote dialogue on new and upcoming legislation such as:

•    EMA Mandate extension (Regulation (EU) 2023/123)
•    HTA Regulation (Regulation (EU) 2021/2282) etc.

The ISG is also the forum to discuss other topics of mutual strategic interest to the Agency and the industry stakeholders.

Documents

Agenda - 13th Industry Standing Group (ISG) meeting

Draft Reference Number: EMA/66610/2025

Highlights - 13th Industry Standing Group (ISG) meeting

Presentation - Commission proposal for a Critical Medicines Act

Presentation - EMA Quality Innovation Group (QIG)

Presentation - ICMRA collaborative assessment pilots

Presentation - Actions arising from previous meeting and other updates (M. Filancia, EMA)

Presentation - Advancing product master data – next steps : strategic recommendations on PMS implementation

Presentation - Medical device expert panels: support to innovation (M. Antunes, EMA)

Presentation - Regulatory/ HTA interface under the HTAR: update on implementation activities (M. Berntgen, EMA)

Presentation - Information ecosystem management & building trust on vaccines (S. Labbe and R. Gonzalez-Quevedo, EMA)

Presentation - Patient experience data in development programs and regulatory decision-making (R. Gonzalez-Quevedo, EMA)

Presentation - EMA/HMA European platform for regulatory science research (L. Barbier and R. Herold, EMA)