Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

EMA is hosting the twelfth industry stakeholder platform on the operation of the centralised procedure for human medicines on 19 June 2024.

• Date:
  Wednesday, 19 June 2024, 13:00 (CEST) - 18:00 (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

EMA is hosting the twelfth industry stakeholder platform on the operation of the centralised procedure for human medicines on 19 June 2024. 

This will be the twelfth in a series of regular meetings between regulators and representatives of industry stakeholder organisations, aiming to foster a constructive exchange on general updates and more focused discussions on specific processes and issues to support continuous improvement. 

This meeting will focus on: 

• updates on ongoing work on use of patient experience data and patient engagement in the centralised procedure; 
• digitalisation (PMS) and IRIS product life cycle management roll-out. 
• information on the initiative to increase the capacity of the EU medicines regulatory network (IncreaseNet); 
• lifecycle management of combination products at post-authorisation; 
• EMA's website; 
• submission preparedness on good manufacturing practice (GMP) aspects; 
• general update on procedural aspects on the centralised procedure; 
• EFPIA will also share results of an internal survey on selected aspects of the centralised procedure and other EMA procedures. 

Documents

Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

Reference Number: EMA/180473/2024

Registration

• Registration by invitation only

Contact point

• [e-mail]