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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
