15th Industry Standing Group (ISG) meeting

• Date:
  Torsdag, 11 december 2025 , 09:00 - 10:00 Amsterdam time (CET)
• Placering:
  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, including:

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

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

Documents

Report - Highlights of the 15th Industry Standing Group (ISG) meeting

Reference Number: EMA/387702/2025

Agenda - 15th Industry Standing Group (ISG) meeting

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

Presentation - New pharmaceutical legislation update : engagement with industry during implementation (M. Carr, EMA)

Presentation - Regulatory / HTA interface under the HTAR – update on implementation activities (N. Manent & D. Karres, EMA)

Presentation - HTA Regulation (V. Barbuto, EC)

Presentation - Publication of information in CVMP agenda and minutes (S. Ribeiro & T. Ferreira, EMA)

Presentation - OPEN framework (N. Perombelon, H. Cuenca & R. Cherif, EMA)

Presentation - Update on Product Management Service (PMS) (H. Hamann & I. Chicharo, EMA)

Presentation - Industry stakeholders feedback on engagement and communication activities (M. Filancia, EMA)

Registration

Registration is by invitation only.