22-04-2021 14:00
The need for better EU policies for health (online event)

Workshops
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EU policies for Health © stock.adobe.com

The COVID-19 pandemic has highlighted the need for European health policy decisions to be guided by scientific and clinical experts.

Aim of the Part I of the workshop is to inform policymakers about the new In Vitro Diagnostics Regulation (IVDR) and its consequences for the EU health system. The application date for the new IVDR is set for May 2022. This regulation contains new provisions to enhance the safety of diagnostics in the EU, and will affect health professionals, academics, labs, industry, and patients.

Part II of the workshop will debate the importance of evidence-based health policies, looking at three case studies; the EU cooperation on health technology assessment (HTA); the use of clinical real-world data to guide healthcare policies; and the need for better evaluation and regulation of artificial intelligence in medicine.


@EP_ScienceTech

#HealthSTOA


PROGRAMME

14:00-14:10 WELCOME

Chair: Alexandra GEESE, MEP and STOA Panel member

14:10-14:25 KEYNOTE SPEECH

Andrzej RYŚ, DG for Health and Food Safety, European Commission

14:25-15:15 PART I: THE IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION (IVDR)

Moderator: Wilfried ELLMEIER, Biomedical Alliance in Europe

Olga TKACHENKO, DG for Health and Food Safety, European Commission

Regulatory framework for in vitro diagnostic medical devices

Christa COBBAERT, Leiden University Medical Center, Netherlands

The new IVDR: opportunities and threats for crisis management and personalized testing

Elizabeth MACINTYRE, Université de Paris, France

Can health care diagnostic providers and EU regulators help each other?

DISCUSSION

15:15-16:20 PART II: THE CASE FOR MORE ROBUST, EVIDENCE-BASED EU POLICIES FOR HEALTH

Moderator: Alan FRASER, Task Force on Regulatory Affairs, Biomedical Alliance in Europe

Ioana-Maria GLIGOR, DG for Health and Food Safety, European Commission

European Health Data Space plans

Aldo MAGGIONI, ANMCO Research Center, Florence, Italy

Using clinical real-world data and professional registries to guide healthcare policies

Piotr SZYMAŃSKI, Regulatory Affairs Committee, European Society of Cardiology

The scientific and clinical rationale for joint health technology assessments

Frank RADEMAKERS, KU Leuven, Belgium

Artificial intelligence in medicine - priorities for evidence and regulation

DISCUSSION

16:20-16:30 CLOSING REMARKS

Tiemo WÖLKEN, MEP and STOA Panel member


Please note the event will be held in English only, without interpretation.