Clinical Data Publication (Policy 0070) webinar - Step 2

The European Medicines Agency (EMA) is hosting a webinar on the next step in the resumption of the Clinical Data Publication (Policy 0070) activities.

• Date:
  Thursday, 14 November 2024 , 15:00 - 16:00 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

At this webinar, EMA presents its plans on the proposed expansion of activities (Step 2) related to Policy 0070 from April 2025 and the handling of legacy procedures, while also providing guidance for applicants and industry stakeholders, including small and medium-sized enterprises intending to submit clinical data for publication. Participants have the opportunity to ask questions. 

Presentations and video recording are made available after the event.

Video recording

Documents

Agenda - Clinical Data Publication (Policy 0070) Step 2 - EMA webinar

Presentation - Clinical data publication: revised scope and updated toolkit (K. Quigley, EMA)

Presentation - Clinical data publication overview process and timelines (S. Garrido-Lestache, EMA)

Presentation - Publication of legacy clinical data (D. Fernández López, EMA)

Presentation - EMA - Health Canada collaboration: Review & publication of Clinical Data Packages (R. Popescu, EMA)