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

• Date:
  сряда, 30 June 2021, Цял ден
• Местоположение:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

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

This meeting will focus on accelerated assessment with ATMPs, a pilot project called 'Market launch of centrally authorised products', launch of IRIS for reporting changes to marketing authorisations, EMA's strategy on digitalisation, a review of working parties, and the CHMP's early contact with patients and consumer groups.

Documents

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

Reference Number: EMA/234664/2021

Highlight report from the sixth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

Reference Number: EMA/381927/2021

Presentation - Accelerated Assessment and Conditional Marketing authorisation (V. Palmi, C. Pothet, M. Schüssler-Lenz)

Presentation - Pilot project ‘Market launch of CAPs' (R. Almeida)

Presentation - Launch of IRIS for reporting changes on Marketing Status (A. Gañán Jiménez)

Presentation - Additional measures to allow experts to focus on COVID-19 activities: Committee's workload and co-Rapporteur involvement (V. Palmi, T. Castelnovo)

Presentation - Interactions with patients across the product lifecycle (N. Bere)

Presentation - EMA Strategy on digitalisation (Z. Frias, P. Arlett, H. Hamann)

Presentation - Review of EMA Working Parties (T. Humphreys)

Presentation - Update on cyberattack (A. Nolte)