¿cómo mejorar la farmacovigilancia de los biosimilares en ... · el plan de gestión de riesgo...
TRANSCRIPT
iquestCoacutemo mejorar la farmacovigilancia de los biosimilares en Ameacuterica Latina Un enfoque de gestioacuten de riesgos
Carlo V Caballero-Uribe MD Internist Rheumatologist MD PhD (c) Associate Profesor of Medicine Universidad del Norte HUN PANLAR President Sep 2017 PanlarCourse
Disclosure
EMC Investigacion Advisory Boards
OliMed Celltrion AbbotLafrancol GSKJansenn MSD Pfizer UCB Roche
Agenda
bull iquestWhat is a Risk Management Plan
bull Steps for a RMP
bull Experience with Biologics
bull Experience in Latam
bull Conclusions
iquestWhat is a Risk Management
Plan
bull A RMP is a set of activities and
interventions designed to
identify characterize and
manage the risks relating to the
use of a medicine
bull An overview of the safety profile
of the medicine a
pharmacovigilance plan and a
risk-minimization plan
ldquoGovernments should actively and regularly promote pharmacovigilancerdquo
Major activities associated with Pharmacovigillance
Pharmacovigilance and Risk Management
Post Authorization Studies are necessary
Pharmacovigilance and Risk Management
Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Disclosure
EMC Investigacion Advisory Boards
OliMed Celltrion AbbotLafrancol GSKJansenn MSD Pfizer UCB Roche
Agenda
bull iquestWhat is a Risk Management Plan
bull Steps for a RMP
bull Experience with Biologics
bull Experience in Latam
bull Conclusions
iquestWhat is a Risk Management
Plan
bull A RMP is a set of activities and
interventions designed to
identify characterize and
manage the risks relating to the
use of a medicine
bull An overview of the safety profile
of the medicine a
pharmacovigilance plan and a
risk-minimization plan
ldquoGovernments should actively and regularly promote pharmacovigilancerdquo
Major activities associated with Pharmacovigillance
Pharmacovigilance and Risk Management
Post Authorization Studies are necessary
Pharmacovigilance and Risk Management
Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Agenda
bull iquestWhat is a Risk Management Plan
bull Steps for a RMP
bull Experience with Biologics
bull Experience in Latam
bull Conclusions
iquestWhat is a Risk Management
Plan
bull A RMP is a set of activities and
interventions designed to
identify characterize and
manage the risks relating to the
use of a medicine
bull An overview of the safety profile
of the medicine a
pharmacovigilance plan and a
risk-minimization plan
ldquoGovernments should actively and regularly promote pharmacovigilancerdquo
Major activities associated with Pharmacovigillance
Pharmacovigilance and Risk Management
Post Authorization Studies are necessary
Pharmacovigilance and Risk Management
Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
iquestWhat is a Risk Management
Plan
bull A RMP is a set of activities and
interventions designed to
identify characterize and
manage the risks relating to the
use of a medicine
bull An overview of the safety profile
of the medicine a
pharmacovigilance plan and a
risk-minimization plan
ldquoGovernments should actively and regularly promote pharmacovigilancerdquo
Major activities associated with Pharmacovigillance
Pharmacovigilance and Risk Management
Post Authorization Studies are necessary
Pharmacovigilance and Risk Management
Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Major activities associated with Pharmacovigillance
Pharmacovigilance and Risk Management
Post Authorization Studies are necessary
Pharmacovigilance and Risk Management
Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Post Authorization Studies are necessary
Pharmacovigilance and Risk Management
Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Steps for a
RMP
bull Detection
bull Assessment
bull Minimisation
bull Communication
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Risk Detection and
Assessment
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Risk Minimisation and
Communication
Pharmacoepidemiol Drug Saf 2010 Jul19(7)661-9 doi 101002pds1948
Biosimilars pharmacovigilance and risk management
Zuntildeiga L1 Calvo B
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Biologic
Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi101038nrrheum201781
Published online 01 June 2017
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Biologic
Registries
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Biologic Registries in
LatamBiobadamerica
REALPANLARhellip
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Requisitos para la aprobacioacuten de
Medicamentos Biosimilares en
Colombia
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
ldquoGuiacutea de elaboracioacuten planes de gestioacuten de riesgo que considere las
distintas categoriacuteas de medicamentos bioloacutegicosrdquo
El plan de gestioacuten de riesgo deberaacute permitir la optimizacioacuten del
perfil de efectividad y seguridad (beneficioseventos adversos) del
tratamiento en la praacutectica cliacutenica habitual considerando la
informacioacuten derivada de todas las fases de desarrollo del
medicamento y la evidencia global
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Trends in Pharmacovigillance
bullPharmacovigilance Outsourcing (PVO)
bull Secondary Data Sources that Contribute to Widespread ADR Reporting Sentinel Initiative
bull Cloud-Based Reporting to Bring a Robust Global Database of ADRs
bull Big Data to Protect and Assimilate Huge Amounts of Information
bull Data Analytics to Mine Insights
bull Automation for Non-Value-Adding Tasks in the PVO Process
bull Artificial Intelligence to Turn PVO into a Predictive Science
bull An overview of the safety profile of the medicine a pharmacovigilance plan and a risk-minimization plan
The worldwide market for Pharmacovigilance services is
projected to be worth $61 billion in revenue by 2020
Industry Trends Shaping the future of Pharmacovigilance
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Conclusions
bull RMP are necessary optimize the profile and riskbenefit ratio of different treatments
bull Biologic experience show that registries are and important way to gather information about drugs
bull RMP should be obligatory to approve a biosimilar
bull We must encourage a Pan American registry for Biologics and Biosimilar
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo
Los Esperamos
24 hours ago
More
ldquoComo no sabiacutean que era imposible helliplo hicieronrdquo
They did not know it was impossible so they did it ldquo