Industry stakeholder platform on the operation of the centralised procedure

• Date:
  Friday, 24 April 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This is the first event in a series of upcoming, semi-annual meetings between regulators and representatives of industry stakeholder organisations. It aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The meeting is providing an update on the current operations, achievements so far, and planned improvements. Particular focus is on the interface in interactions with the applicant during evaluation procedures as well as the management of variations. Registration by invitation only. Registration closed.

Documents

Highlights from the European Medicines Agency industry platform meeting held on 24 April 2015 on the operation of the centralised procedure

Reference Number: EMA/290883/2015

Agenda - Industry stakeholder platform on the operation of the centralised procedure

Reference Number: EMA/207894/2015

Presentation - Status update of changes to the operations in the centralised procedure (Evdokia Korakianiti)

Presentation - European Medicines Agency product team and applicant/marketing authorisation holder interaction (Michael Berntgen)

Presentation - Perspective of EPL and PM regarding interactions with applicants (Pavel Balabanov, Leonor Enes, Viktor Vlcek)

Summary:

Industry stakeholder platform on the operation of the centralised procedure meeting

Presentation - Procedure management of variations (Alberto Ganan, Iordanis Gravanis)

Presentation - New practice for the management of clarification meetings (Pavel Balabanov)

Presentation - European Medicines Agency survey on "Centralised post-marketing authorisation procedures" 2015 (Marie-Helene Pinheiro)

Presentation - Raise the game (Enrica Alteri)