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

• Date:
  Monday, 3 July 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The objective of these platform meetings is to foster a constructive dialogue with industry stakeholders on operational matters of the centralised procedure and to identify opportunities for improvement. The focus of this fourth meeting is the outcome of the tripartite survey by rapporteurs, industry and the European Medicines Agency on initial marketing authorisation applications. Other topics include an exchange of experience with the new accelerated assessment process and the new linguistic review process, share experience with the use of the effects table to support benefit-risk discussions and to get industry feedback on some important updates in our post-authorisation procedures.

Documents

Highlights from the fourth European Medicines Agency industry platform meeting held on the 3rd of July 2017 on the operation of the centralised procedure for human medicinal products

Reference Number: EMA/424893/2017

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

Presentation - Survey to industry, rapporteurs and European Medicines Agency: marketing authorisation application survey results (Fiona Reekie)

Presentation - Accelerated assessment (AA): review of 10 months experience with the new AA process (Victoria Palmi)

Presentation - European Medicines Agency experience on the use of the B/R to the effect table: from rapporteurship to CHMP discussion, to EPAR (Andreas Kouroumalis)

Presentation - English version labelling review: overview of the new process for initial MAAs and data from two years experience (Alexios Skarlatos)

Summary:

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

Presentation - Clinical type II variations: latest process improvements to improve quality of submissions (Iordanis Gravanis)

Presentation - Quality variations: simplification opportunities and improvement of quality of submissions (Alberto Ganan Jimenez)

Presentation - A dedicated post-authorisation measure submission form: an improved way of submitting your PAM to the EMA (Hector Boix Perales)

Presentation - Update on the PSUR roadmap: achieving a common understanding of the PSUR single assessment in Europe (Irene Rager)

Presentation - Exchange between European Medicines Agency and health technology assessment (HTA) bodies to facilitate joint production of relative effectiveness assessments (Michael Berntgen, Michelle Mujoomdar)

Presentation - Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines (Presentation of revised BPG after consultation with industry ...