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

This meeting continues the series of regular exchanges between regulators and representatives of industry stakeholder organisations, aiming to foster constructive dialogue on both general updates and focused discussions to support continuous improvement.
EventHumanMedicines

Polish is available via eTranslation, the European Commission's machine translation service.

Translate to Polish | Important information about machine translation

Data

, -

Położenie

Online
European Medicines Agency, Amsterdam, the Netherlands

Event summary

The meeting covers five main topics:

  • Implementation of the new pharmaceutical legislation, including developments under delivery streams 1, 4 and 6, including:
    • the centralised procedure and committee reform
    • active substance mater file (ASMF)
    • provisions on priority antimicrobial vouchers
    • incentives
    • product information
  • EMA raw data submissions;
  • assessment report (AR) revamp pilot;
  • pre-submission interactions pilot;
  • revision of the quality review of documents (QRD) template, including developments related to packaging and the Packaging and Packaging Waste Regulation.

Documents

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

English (EN) (138.74 KB - PDF)

Opublikowane po raz pierwszy:
Zobacz

Registration

Registration by invitation only.

Share this page