Second industry stakeholder platform on the operation of the centralised procedure for human medicinal products

• Date:
  Monday, 9 November 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The objective of this series of semi-annual meetings between regulators and representatives of industry stakeholder organisations is 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. At the second meeting, the detailed report on the survey on post-authorisation procedures is discussed. Furthermore, specific aspects of variation management for risk management plan updates, experience with the review of mock-ups and specimens as well as a progress report on the revision of guidelines on early access tools is addressed. Registration by invitation only.

Documents

Highlights from the second industry stakeholder platform on the operation of the centralised procedure for human medicinal products held on 9 November 2015

Reference Number: EMA/5702/2016

Agenda - Second industry stakeholder platform on the operation of the centralised procedure for human medicinal products

Reference Number: EMA/633298/2015

Presentation - Optimising early access tools: revision of the guidelines on Accelerated Assessment and Conditional Marketing Authorisation (Tomas Salmonson)

Presentation - Mock ups and specimen review: labelling review and Standards Office (Monica Prizzi)

Presentation - Management of the risk management plan for centrally authorised products in post-authorisation: European Medicines Agency perspective (Iordanis Gravanis)

Presentation - Overview of recent changes in the centralised procedure (Michael Berntgen)

Presentation - European Medicines Agency survey on post-authorisation procedures (Marie-Hà©là¨ne Pinheiro, Alberto Ganan-Jimenez)