EMA Regulatory Science to 2 0 2 5 Session 1 : Responding to the - - PowerPoint PPT Presentation

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Apr 22, 2023 500 likes •627 views

EMA Regulatory Science to 2 0 2 5 Session 1 : Responding to the needs of the 2 1 st century patient. Addressing challenges and opportunities across the European Regulatory Fram ew ork Olga Solom on Horizon Europe is the Commission proposal

SLIDE 1

Session 1 : Responding to the needs of the 2 1 st century

patient. Addressing challenges and opportunities across

the European Regulatory Fram ew ork Olga Solom on

EMA – Regulatory Science to 2 0 2 5

SLIDE 2

Horizon Europe

is the Commission proposal for a research and innovation funding programme for seven years (2021-2027) to strengthen the EU's scientific and technological bases to boost Europe's innovation capacity, com petitiveness and jobs to deliver on citizens' priorities and sustain our socio-econom ic m odel and values

SLIDE 3

Real w orld data in health care

Multiple sources of data:
Clinical databases (prescriptions, EHR, registries)
Clinical trials
Imaging data
'mc data'
Published literature
Regulatory pharmacovigilance data
Social media/ Health data
Clinical databases (prescriptions,

EHR, registries)

Clinical trials
Imaging data
'Omic data'
Published literature
Regulatory pharmacovigilance data
Social media/ mHealth data

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Com m ission Com m unication of 2 5 April 3 Priority areas on digitising Health and Care

SLIDE 5

EU Legislation on Clinical Trials Regulation EU No 536/ 2014

Simplified

and harmonized administrative provisions

Closer

coordination between MS for international CTs

Increased transparency

SLIDE 6

Evaluation of the paediatric and of the orphan regulations

Paediatric study/report on

Reg. 1901/2006:

Pulic health impact Economic impact

Incentives study

Impact on innovation, availability accessibility

Gap Analysis study for evaluation of

rphans

EVALUATION

SLIDE 7

Evaluation

Identification of the problems;
Strengths and weaknesses of paediatric and orphan

legislations alone and combined;

How incentives have been used;
Finalisation by the end of 2019;
Base for the next Commission to decide future

policy choices.

SLIDE 8

From Directives to Regulations

Directive 90/ 385/ EEC on active implantable medical devices Directive 93/ 42/ EEC on medical devices → Regulation on MD ( 2 0 1 7 / 7 4 5 ) Directive 98/ 79/ EC on in vitro diagnostic medical devices → Regulation on I VD ( 2 0 1 7 / 7 4 6 ) Necessity to harmonise the legislation in Member States and to adapt to health scandals: PIP implants; metal on metal hip implants…

SLIDE 9

Health Technology Assessm ent ( HTA)

Proposal for a Regulation

31 January 2018

SLIDE 10

I m plem entation and Looking to the future

SLIDE 11