evaluación y regulación: interfaz y flujo de la i+d de las...

César Hernández García

Jefe de DepartamentoMedicamentos de Uso HumanoAgencia Española de Medicamentos y Productos Sanitarios

Evaluación y Regulación: interfaz y flujo de la I+D de las nuevas moléculas

Early access programmes

Clinical Trials

Early access programmes

Clinical Trials

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Early access programmes

EUInnovationNetwork

NCA Offices

ITF

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

Coordination andSupport Action

Early access programmes

Scientific Advice

National SA

Centralized SAEU

InnovationNetwork

NCA Offices

ITF

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

Coordination andSupport Action

Early access programmes

EPAR

Conditional MA

MA ExceptionalCircumstances

Scientific Advice

National SA

Centralized SA

PRIMEaccelerate assessment

EUInnovationNetwork

NCA Offices

ITF

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

EMA

Coordination andSupport Action

Early access programmes

EPAR

Relative effectiveness assessment (REA)

Conditional MA

MA ExceptionalCircumstances

Scientific Advice

National SA

Centralized SA ParallelConsultation

PRIMEaccelerate assessment

EUInnovationNetwork

NCA Offices

ITF

EUnetHTA

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

EMA EMA Committees

Coordination andSupport Action

Early access programmes

EPAR

Relative effectiveness assessment (REA)

Conditional MA

MA ExceptionalCircumstances

Scientific Advice

National SA

Centralized SA ParallelConsultation

PRIMEaccelerate assessment

EUInnovationNetwork

NCA Offices

ITF

EUnetHTA

Adaptive pathways

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

Coordination andSupport Action

Repurposing

Early access programmes

EPAR

Relative effectiveness assessment (REA)

Conditional MA

MA ExceptionalCircumstances

Scientific Advice

National SA

Centralized SA ParallelConsultation

PRIMEaccelerate assessment

EUInnovationNetwork

NCA Offices

ITF

EUnetHTA

Adaptive pathways

Real Worldevidence

Registries

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

Coordination andSupport Action

Repurposing

Early access programmes

EPAR

Relative effectiveness assessment (REA)

Conditional MA

MA ExceptionalCircumstances

CTFG

Ad hoc CT Expert Group

Scientific Advice

National SA

Centralized SA ParallelConsultation

PRIMEaccelerate assessment

EUInnovationNetwork

NCA Offices

ITF

EUnetHTA

Adaptive pathways

Real Worldevidence

Registries

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

Standing Committee

Safe and Timely Access to Medicines for Patients (STAMP) Expert Group

HMA and HMA Experts Groups (MAWP and 2020 Strategy)

Pharma Committee

EMA EMA Committees

IMI projects

Coordination andSupport Action

Repurposing

Early access programmes

EPAR

Relative effectiveness assessment (REA)

Conditional MA

MA ExceptionalCircumstances

CTFG

Ad hoc CT Expert Group

Scientific Advice

National SA

Centralized SA ParallelConsultation

PRIMEaccelerate assessment

EUInnovationNetwork

NCA Offices

ITF

EUnetHTA

HTA network

SynergyGroup

Adaptive pathways

Real Worldevidence

Registries

CT LegislationPharma Legislation

Cross Border Directive (new proposal on HTA 2018)

Transparency Directive

Clinical Trials

Standing Committee

Safe and Timely Access to Medicines for Patients (STAMP) Expert Group

Repurposing

HMA and HMA Experts Groups (MAWP and 2020 Strategy)

Pharma Committee

EMA

CAPR Network

Project Euripid

EMA CommitteesEMA-EUnetHTAcollaboration

IMI projects

Coordination andSupport Action

Doce minutos… algunas (3) ideas(algunas contracorriente)

recolocar

incentivoslos

Desarrollar nuevas estrategias para el desarrollo de medicamentossin caer en la ingenuidad(lo cual no debe ser fácil, pero para que nos vamos a quedar con lo fácil)

Finalmente, o trabajamos juntos o

seguimos como hasta ahora…

GRACIAS