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

• Date:
  Donnerstag, 3 Dezember 2020, Ganztägig
• Ort:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This is the fifth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It aims to foster a constructive exchange with industry stakeholders on general updates and more focused discussions on specific processes and issues to support continuous improvement.

This meeting focuses on KPIs for IMAA, IRIS for marketing status, an analysis on accelerated assessments, highlights from the working parties operational model project and eCPPS.

Documents

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

Highlight report - Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

Reference Number: EMA/652244/2020

Presentation - Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines - Introduction (R.Cherif, EMA)

Presentation - Reporting marketing status to EMA via IRIS (A.Ganan Jimenez, EMA)

Presentation - KPIs Centralised Procedure: Initial marketing authorization application and use of checklist (C.Blanc, EMA)

Presentation - EMA experience on eCPPs (A.Ganan Jimenez, EMA)

Presentation - Accelerating patients’ access to medicines that address unmet medical needs (V.Palmi, C.Pothet, EMA)

Presentation - Working parties new operational model (T.Humphreys, EMA)