An event organised in the framework of the French Presidency of the Council of the European Union (1).
The Real World Evidence Conference, organized by the ANSM was held on March 8 and 9.
The use of real-world data is a rapidly expanding area in healthcare product development and monitoring due to increased capabilities for massive data collection based on improved computing and digital capabilities. The recent pandemic has significantly accelerated data sharing, but the impact is much broader...
The Real World Data conference was an opportunity to give voice to European experts, share experiences from different countries and discuss in a roundtable.
(1) This event is not organized by the French Government but is authorized to use the French Presidency of the Council of the European Union logo.
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00:00 Générique 00:00:16 Introduction Christelle Ratignier Carbonneil, Director general, ANSM, France 00:07:56 Reinforced pharmacovigilance of COVID-19 vaccines surveillance in France 00:28:02 The French Regional Pharmacovigilance Network in COVID-19 Vaccines safety monitoring 00:51:00 Questions & Answer 00:56:45 An European pharmacovigilance system in the COVID-19 vaccines surveillance –the Norwegian experience 01:20:28 Questions & Answer 01:28:56 Pharmaco-epidemiology studies 02:16:36 Questions & Answer 02:18:51 Information and transparency 02:24:15 Real World Data in the European decision 02:39:24 Questions & Answer 02:43:35 Conclusion session 1 02:48:00 Introduction session 2 02:51:01 Academia-regulator collaboration in covid-19 03:25:55 Questions & Answer 03:37:31 An Italian Distributed Multi‑Database Healthcare Network:The VALORE Project 04:10:19 Questions & Answer 04:28:20 Generating evidence using an international common data model 04:52:17 Questions & Answer 05:04:04 Enhancing use of real-world evidence for regulatory purposes: DARWIN EU® and the EMA registry initiative 05:36:32 Questions & Answer 05:43:42 Conclusion session 2
