Ninth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicine

• Date:
  четвъртък, 24 November 2022 , 13:00 - 17:30 Amsterdam time (CET)
• Местоположение:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

EMA is hosting the Industry stakeholder platform on the operation of the centralised procedure for human medicines on the 24th November 2022. This will be the 9th 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 electronic submissions, DADI, Type II validation Team and Assessment Report revamp project. Information and discussion to be held on Regulatory Reliance, Pre-submission meetings, Network sustainability on ePI and the Raw Data Pilot.

Documents

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

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

Reference Number: EMA/907045/2022

Presentation 1a - Update on electronic submissions & DADI- (K. Hamilton, K. Puusaar)

Presentation 2b - EMA International collaboration in the review of medicines (V. Palmi-Reig, M. Harvey-Allchurch)

Presentation 3b - Pre-submissions meetings (M. Kollb-Sielecka, G. Bec)

Presentation 4a - Network sustainability and update on CHMP AR revamp project (F. Day)

Presentation 5 - Update on Type II validation team (F. Day, L. Liebers, A. Begic, C. Forster)

Presentation 6 - EMA's Clinical Trials Raw Data project (E. Psarelli & F. Lasch)

Presentation 7b - ePI - Update on Electronic Product Information (J. Garcia, E. Scanlan)