Organization - Asset and portfolio impact assessment
JSC - Strategy development, briefing book and meeting execution
Organization - Ways of working and ownership model development
Other - External stakeholder engagement
Organization - Industry benchmarking and monitoring
Other - Business training delivery
JCA - Early PICO simulation
JCA - Strategy and gap analysis
JCA - Evidence generation planning and execution
JCA - Late PICO simulation
JCA - Dossier development
JCA - In-depth project management
JCA - Post-submission and local HTA coordination
Q3 '25
Q4 '25
Q1 '26
Q2 '26
Q3 '26
Q4 '26
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
JCA - Dossier development
12 months
12 months
Project
Duration
Duration
As we approach the expansion of the EU Health Technology Assessment Regulation (HTAR) for orphan medicines in 2028, manufacturers must start considering how they adapt their organizations and ways of working to account for the new joint scientific consultation (JSC) and joint clinical assessment (JCA) procedures. Given the range of changes required, understanding what activities to execute and when can be a difficult task. To support your decision-making, IQVIA has consolidated its experience across all prior EU HTAR projects into one simple tool, showing you the timing and type of support offered for JCA, JSC, organizational readiness and other readiness activities.
Tool context statement
January 2028
June 2028
January 2029
June 2029
Q1 '26
Q2 '26
Q3 '26
Q4 '26
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
Q2 '28
Q3 '28
Q3 '26
Q4 '26
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
Q2 '28
Q3 '28
Q4 '28
Q1 '29
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
Q2 '28
Q3 '28
Q4 '28
Q1 '29
Q2 '29
Q3 '29
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
January 2028
January 2028
January 2028
June 2028
June 2028
June 2028
January 2029
January 2029
January 2029
June 2029
June 2029
June 2029
January 2028
January 2028
January 2028
June 2028
June 2028
June 2028
January 2029
January 2029
January 2029
June 2029
June 2029
June 2029
January 2028
January 2028
January 2028
June 2028
June 2028
June 2028
January 2029
January 2029
January 2029
June 2029
June 2029
June 2029
Draft and update the full JCA dossier and appendices based on existing JCA strategy and material, including strategy & dossier recalibration following registrational trial readout and final scope confirmation. Includes regular internal and external communications on the latest JCA and JSC developments and planning, where relevant
JCA - Early PICO simulation
Conduct asset-specific PICO simulation, consolidation and prioritization to support definition of early evidence requirements and trial design
3 months
3 months
Project
Duration
Duration
JCA - Late PICO simulation
Conduct asset-specific PICO simulations, consolidation and prioritization across the development timeline to anticipate JCA scope and define overall JCA strategies
3 months
3 months
Project
Duration
Duration
JCA - Strategy and gap analysis
Leveraging PICO simulations and asset evidence plans, develop a JCA evidence generation strategy with actionable planning and implementation steps based on the gap analysis of the asset evidence package versus expected JCA requirements
2 months
2 months
Project
Duration
Duration
JCA - Evidence generation planning and execution
Leverage JCA strategy, JSC outputs, PICO simulations and any other strategy sources to develop a robust evidence plan (e.g., , SLR, ITC, economic models, external comparator, payer SAP, GVD) for execution up to development of the JCA dossier
18 months
12 months
Project
Duration
Duration
JCA - Post-submission and local HTA coordination
Conduct post-submission activities, such as response to completeness check, response to ad-hoc questions, fact check of draft JCA report and any other ad-hoc evidence requests from the JCA Coordination Group. Support local P&R activities, including global model development and adaptation, delta dossier development, objection handler development and pricing negotiation support
3 months
3 months
Project
Duration
Duration
JSC - Strategy development, briefing book and meeting execution
Draft and update the full JSC briefing book, prepare for JSC advice meeting and make strategic recommendations on how to optimise pivotal trial design based on the advice
6 months
4 months
Project
Duration
Duration
JCA - In-depth project management
Manage regular internal communications on the latest internal and external JCA/JSC developments, and provide PMO support for relevant initiatives
6 months
2 months
Project
Duration
Duration
Organization - Asset and portfolio impact assessment
Assess the impact of JCA on current and future portfolio assets, assess eligibility of assets for JSC and the risks and benefits of applying for JSC
3 months
3 months
Project
Duration
Duration
Organization - Ways of working and ownership model development
Adapt the existing access strategy framework to account for the impact of EU HTA regulation, establish new internal ways of working and ownership models to optimize for the new JCA and JSC processes
9 months
3 months
Project
Duration
Duration
Other - External stakeholder engagement
Engage with key clinical, medical and EU HTA stakeholders prior to, during and following any JSC or JCA procedures
24 months
6 months
Project
Duration
Duration
Organization - Industry benchmarking and monitoring
Conduct a peer benchmarking exercise to understand companies' approach to JCA and JSC, and relative level of readiness, and continue to monitor external and competitive elements
24 months
2 months
Project
Duration
Duration
Other - Business training delivery
Develop training materials for a range of internal stakeholders on JCA and JSC process, requirements and skills
1 months
1 months
Project
Duration
Duration
Click each activity bar for more info
Defined activity Ongoing activity, no specific end date
1. Select your expected EMA filing date for your first orphan asset
2. Click the info icon to learn about the EU HTA planner
Organization - Asset and portfolio impact assessment
Start date: Q1 '27 | Duration: 3 months
JSC - Strategy development, briefing book and meeting execution
Start date: Q2 '27 | Duration: 6 months
Organization - Ways of working and ownership model development
Start date: Q2 '27 | Duration: 9 months
Other - External stakeholder engagement
Start date: Q4 '27 | Duration: 24 months
Organization - Industry benchmarking and monitoring
Start date: Q4 '27 | Duration: 24 months
Other - Business training delivery
Start date: Q3 '29 | Duration: 1 month
JCA - Early PICO simulation
Start date: Q3 '27 | Duration: 3 months
JCA - Strategy and gap analysis
Start date: Q4 '27 | Duration: 2 months
JCA - Evidence generation planning and execution
Start date: Q4 '27 | Duration: 18 months
JCA - Late PICO simulation
Start date: Q3 '28 | Duration: 3 months
JCA - Dossier development
Start date: Q3 '28 | Duration: 12 months
JCA - In-depth project management
Start date: Q1 '29 | Duration: 6 months
JCA - Post-submission and local HTA coordination
Start date: Q3 '29 | Duration: 3 months
Organization - Asset and portfolio impact assessment
Start date: Q3 '26 | Duration: 3 months
JSC - Strategy development, briefing book and meeting execution
Start date: Q4 '26 | Duration: 6 months
Organization - Ways of working and ownership model development
Start date: Q4 '26 | Duration: 9 months
Other - External stakeholder engagement
Start date: Q2 '27 | Duration: 24 months
Organization - Industry benchmarking and monitoring
Start date: Q2 '27 | Duration: 24 months
Other - Business training delivery
Start date: Q1 '29 | Duration: 1 month
JCA - Early PICO simulation
Start date: Q1 '27 | Duration: 3 months
JCA - Strategy and gap analysis
Start date: Q2 '27 | Duration: 2 months
JCA - Evidence generation planning and execution
Start date: Q3 '27 | Duration: 18 months
JCA - Late PICO simulation
Start date: Q1 '28 | Duration: 3 months
JCA - Dossier development
Start date: Q1 '28 | Duration: 12 months
JCA - In-depth project management
Start date: Q3 '28 | Duration: 6 months
JCA - Post-submission and local HTA coordination
Start date: Q1 '29 | Duration: 3 months
Organization - Asset and portfolio impact assessment
Start date: Q1 '25 | Duration: 3 months
JSC - Strategy development, briefing book and meeting execution
Start date: Q2 '26 | Duration: 6 months
Organization - Ways of working and ownership model development
Start date: Q2 '26 | Duration: 9 months
Other - External stakeholder engagement
Start date: Q4 '26 | Duration: 24 months
Organization - Industry benchmarking and monitoring
Start date: Q4 '26 | Duration: 24 months
Other - Business training delivery
Start date: Q3 '28 | Duration: 1 month
JCA - Early PICO simulation
Start date: Q3 '26 | Duration: 3 months
JCA - Strategy and gap analysis
Start date: Q4 '26 | Duration: 2 months
JCA - Evidence generation planning and execution
Start date: Q4 '26 | Duration: 18 months
JCA - Late PICO simulation
Start date: Q3 '27 | Duration: 3 months
JCA - Dossier development
Start date: Q3 '27 | Duration: 12 months
JCA - In-depth project management
Start date: Q1 '28 | Duration: 6 months
JCA - Post-submission and local HTA coordination
Start date: Q3 '28 | Duration: 3 months
Organization - Asset and portfolio impact assessment
Start date: Q3 '25 | Duration: 3 months
JSC - Strategy development, briefing book and meeting execution
Start date: Q4 '25 | Duration: 6 months
Organization - Ways of working and ownership model development
Start date: Q4 '25 | Duration: 9 months
Other - External stakeholder engagement
Start date: Q2 '26 | Duration: 24 months
Organization - Industry benchmarking and monitoring
Start date: Q2 '26 | Duration: 24 months
Other - Business training delivery
Start date: Q1 '28 | Duration: 1 month
JCA - Early PICO simulation
Start date: Q1 '26 | Duration: 3 months
JCA - Strategy and gap analysis
Start date: Q2 '26 | Duration: 2 months
JCA - Evidence generation planning and execution
Start date: Q3 '26 | Duration: 18 months
JCA - Late PICO simulation
Start date: Q1 '27 | Duration: 3 months
JCA - Dossier development
Start date: Q1 '27 | Duration: 12 months
JCA - In-depth project management
Start date: Q3 '27 | Duration: 6 months
JCA - Post-submission and local HTA coordination
Start date: Q1 '28 | Duration: 3 months
2. Tap the info icon to learn about the EU HTA planner
Defined activity
Ongoing activity, no specific end date
Tap each activity bar for more information
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
Other - Business training delivery
Develop training materials for a range of internal stakeholders on JCA and JSC process, requirements and skills
1 months
1 months
Project
Duration
Duration
Organization - Industry benchmarking and monitoring
Conduct a peer benchmarking exercise to understand companies' approach to JCA and JSC, and relative level of readiness, and continue to monitor external and competitive elements
24 months
2 months
Project
Duration
Duration
Other - External stakeholder engagement
Engage with key clinical, medical and EU HTA stakeholders prior to, during and following any JSC or JCA procedures
24 months
6 months
Project
Duration
Duration
Organization - Ways of working and ownership model development
Adapt the existing access strategy framework to account for the impact of EU HTA regulation, establish new internal ways of working and ownership models to optimize for the new JCA and JSC processes
9 months
3 months
Project
Duration
Duration
Organization - Asset and portfolio impact assessment
Assess the impact of JCA on current and future portfolio assets, assess eligibility of assets for JSC and the risks and benefits of applying for JSC
3 months
3 months
Project
Duration
Duration
JCA - In-depth project management
Manage regular internal communications on the latest internal and external JCA/JSC developments, and provide PMO support for relevant initiatives
6 months
2 months
Project
Duration
Duration
JSC - Strategy development, briefing book and meeting execution
Draft and update the full JSC briefing book, prepare for JSC advice meeting and make strategic recommendations on how to optimise pivotal trial design based on the advice
6 months
4 months
Project
Duration
Duration
JCA - Post-submission and local HTA coordination
Conduct post-submission activities, such as response to completeness check, response to ad-hoc questions, fact check of draft JCA report and any other ad-hoc evidence requests from the JCA Coordination Group. Support local P&R activities, including global model development and adaptation, delta dossier development, objection handler development and pricing negotiation support
3 months
3 months
Project
Duration
Duration
JCA - Evidence generation planning & execution
Leverage JCA strategy, JSC outputs, PICO simulations and any other strategy sources to develop a robust evidence plan (e.g., , SLR, ITC, economic models, external comparator, payer SAP, GVD) for execution up to development of the JCA dossier
18 months
12 months
Project
Duration
Duration
JCA - Strategy and gap analysis
Leveraging PICO simulations and asset evidence plans, develop a JCA evidence generation strategy with actionable planning and implementation steps based on the gap analysis of the asset evidence package versus expected JCA requirements
2 months
2 months
Project
Duration
Duration
JCA - Late PICO simulation
Conduct asset-specific PICO simulations, consolidation and prioritization across the development timeline to anticipate JCA scope and define overall JCA strategies
3 months
3 months
Project
Duration
Duration
JCA - Early PICO simulation
Conduct asset-specific PICO simulation, consolidation and prioritization to support definition of early evidence requirements and trial design
3 months
3 months
Project
Duration
Duration
JCA - Dossier development
Draft and update the full JCA dossier and appendices based on existing JCA strategy and material, including strategy & dossier recalibration following registrational trial readout and final scope confirmation. Includes regular internal and external communications on the latest JCA and JSC developments and planning, where relevant
12 months
12 months
Project
Duration
Duration
As we approach the expansion of the EU Health Technology Assessment Regulation (HTAR) for orphan medicines in 2028, manufacturers must start considering how they adapt their organizations and ways of working to account for the new joint scientific consultation (JSC) and joint clinical assessment (JCA) procedures. Given the range of changes required, understanding what activities to execute and when can be a difficult task. To support your decision-making, IQVIA has consolidated its experience across all prior EU HTAR projects into one simple tool, showing you the timing and type of support offered for JCA, JSC, organizational readiness and other readiness activities.
Tool context statement
Select your expected EMA filing date for your first orphan asset
JCA - Dossier support
JCA - Early PICO simulation
JCA - Late PICO simulation
JCA - Strategy & gap analysis
JCA - Dossier full pilot
JCA - Post submission and local HTA coordination
JCA - Briefing book & meeting support
Organization - Industry benchmarking
Organization - Asset & portfolio impact assessment
Organization - Ways of working & ownership model
Other - Regular PMO support
Other - Thought leadership
Other - Business training
Q3 '25
Q4 '25
Q1 '26
Q2 '26
Q3 '26
Q4 '26
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
January 2028
June 2028
January 2029
June 2029
Project
Description
Time to start prior to EMA submission
Duration
Organizational readiness - Asset and portfolio impact assessment
Assess the impact of JCA on current and future portfolio assets, assess eligbility of assets for JSC and the risks & benefits of applying
12 months
12 months
Organizational readiness - Industry benchmarking
Conduct a peer benchmarking exercise to understand companies' approach to JCA and JSC, and relative level of readiness
6 months
2 months
Project
Description
Time to start prior to EMA submission
Duration
JSC - Briefing book & meeting support
Draft and update the full JSC briefing book, prepare for JSC advice meeting and make strategic recommendations on how to optimise pivotal trial design based on the advice
30 months
4 months
Project
Description
Time to start prior to EMA submission
Duration
JCA - Post-submission and local HTA coordination
Support post-submission activities, such as response to ad-hoc questions and evidence generation for additional data requests. Support local P&R activities, including global model development and adaptation, delta dossier development, objection handler development and pricing negotiation support
0 months
3 months
Project
Description
Time to start prior to EMA submission
Duration
JCA - Dossier full pilot
Conduct a full-scale pilot of a JCA dossier development, including drafting and reviewing to established timelines, to pressure test and improve internal ways of working and execution
24 months
12 months
Project
Description
Time to start prior to EMA submission
Duration
JCA - Strategy & gap analysis
Leveraging PICO simulations and asset evidence plans, develop a JCA evidence generation strategy with actionable planning and implementation steps based on the gap analysis of the asset evidence package versus expected JCA requirements
18 months
2 months
Project
Description
Time to start prior to EMA submission
Duration
JCA - Late PICO simulation
Conduct asset-specific PICO simulations, consolidation and prioritization across the development timeline to anticipate JCA scope and define overall JCA strategies
12 months
3 months
Project
Description
Time to start prior to EMA submission
Duration
JCA - Early PICO simulation
Conduct asset-specific PICO simulation, consolidation and prioritization to support definition of early evidence requirements and trial design
24 months
3 months
Project
Description
Time to start prior to EMA submission
Duration
JCA - Dossier support
Draft and update the full JCA dossier and appendices based on existing JCA strategy and materials
12 months
12 months
Project
Description
Time to start prior to EMA submission
Duration
Organizational readiness - Ways of working & ownership model
Adapt the existing access strategy framework to account for the impact of EU HTA regulation, establish new internal ways of working and ownership models to optimize for the new JCA and JSC processes
6 months
3 months
Project
Description
Time to start prior to EMA submission
Duration
Other support - Regular PMO support
Support with regular internal communications on the latest internal and external JCA/JSC developments, and provide PMO support for internal initiatives
6 months
6 months
Project
Description
Time to start prior to EMA submission
Duration
Other support - Thought leadership
Engage in whitepaper authorship, peer-reviewed article authorship and conference attendance to help shape the industry approach to JCA and JSC
24 months
2 months
Project
Description
Time to start prior to EMA submission
Duration
Other support - Training
Develop bespoke training materials for a range of internal stakeholders on JCA and JSC process, requirements and skills
3 months
1 months
Project
Description
Time to start prior to EMA submission
Duration
Tool context statement
As we approach the expansion of the EU Health Technology Assessment Regulation (HTAR) for orphan medicines in 2028, manufacturers must start considering how they adapt their organizations and ways of working to account for the new joint scientific consultation (JSC) and joint clinical assessment (JCA) procedures.
Given the range of changes required, understanding what activities to execute and when can be a difficult task. To support your decision-making, IQVIA has consolidated its experience across all prior EU HTAR projects into one simple tool, showing you the timing and type of support offered for JCA, JSC, organizational readiness and other readiness activities.
Tool context statement
Q3 '25
Q1 '27
JCA - Late PICO simulation
JCA - Strategy & gap analysis
JCA - Dossier full pilot
JCA - Post submission and local HTA coordination
JCA - Briefing book & meeting support
Organization - Industry benchmarking
Organization - Asset & portfolio impact assessment
Organization - Ways of working & ownership model
Other - Regular PMO support
Other - Thought leadership
Other - Business training
January 2028
June 2028
January 2029
June 2029
January 2028
June 2028
January 2029
June 2029
January 2028
June 2028
January 2029
June 2029
Q3 '25
Q4 '25
Q1 '26
Q2 '26
Q3 '26
Q4 '26
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
Q3 '25
Q4 '25
Q1 '26
Q2 '26
Q3 '26
Q4 '26
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
Q3 '25
Q4 '25
Q1 '26
Q2 '26
Q3 '26
Q4 '26
Q1 '27
Q2 '27
Q3 '27
Q4 '27
Q1 '28
June 2029
January 2029
June 2028
January 2028
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
January 2028
January 2028
June 2028
June 2028
January 2029
January 2029
June 2029
June 2029
Click each activity bar for more information
Other support - Training
Develop bespoke training materials for a range of internal stakeholders on JCA and JSC process, requirements and skills
3 months
1 months
Project
Time to start prior to EMA submission
Duration
Other support - Thought leadership
Engage in whitepaper authorship, peer-reviewed article authorship and conference attendance to help shape the industry approach to JCA and JSC
24 months
2 months
Project
Time to start prior to EMA submission
Duration
Other support - Regular PMO support
Support with regular internal communications on the latest internal and external JCA/JSC developments, and provide PMO support for internal initiatives
6 months
6 months
Project
Time to start prior to EMA submission
Duration
Organizational readiness - Ways of working & ownership model
Adapt the existing access strategy framework to account for the impact of EU HTA regulation, establish new internal ways of working and ownership models to optimize for the new JCA and JSC processes
6 months
3 months
Project
Time to start prior to EMA submission
Duration
Organizational readiness - Asset and portfolio impact assessment
Assess the impact of JCA on current and future portfolio assets, assess eligbility of assets for JSC and the risks & benefits of applying
12 months
12months
Project
Time to start prior to EMA submission
Duration
Organizational readiness - Industry benchmarking
Conduct a peer benchmarking exercise to understand companies' approach to JCA and JSC, and relative level of readiness
6 months
2 months
Project
Time to start prior to EMA submission
Duration
JSC - Briefing book and meeting support
Draft and update the full JSC briefing book, prepare for JSC advice meeting and make strategic recommendations on how to optimise pivotal trial design based on the advice
30 months
4 months
Project
Time to start prior to EMA submission
Duration
JCA - Post-submission and local HTA coordination
Support post-submission activities, such as response to ad-hoc questions and evidence generation for additional data requests. Support local P&R activities, including global model development and adaptation, delta dossier development, objection handler development and pricing negotiation support
0 months
3 months
Project
Time to start prior to EMA submission
Duration
JCA - Dossier full pilot
Conduct a full-scale pilot of a JCA dossier development, including drafting and reviewing to established timelines, to pressure test and improve internal ways of working and execution
24 months
12 months
Project
Time to start prior to EMA submission
Duration
JCA - Strategy & gap analysis
Leveraging PICO simulations and asset evidence plans, develop a JCA evidence generation strategy with actionable planning and implementation steps based on the gap analysis of the asset evidence package versus expected JCA requirements
18 months
2 months
Project
Time to start prior to EMA submission
Duration
JCA - Late PICO simulation
Conduct asset-specific PICO simulations, consolidation and prioritization across the development timeline to anticipate JCA scope and define overall JCA strategies
12 months
3 months
Project
Time to start prior to EMA submission
Duration
JCA - Early PICO simulation
Conduct asset-specific PICO simulation, consolidation and prioritization to support definition of early evidence requirements and trial design
24 months
3 months
Project
Time to start prior to EMA submission
Duration
JCA - Dossier support
Draft and update the full JCA dossier and appendices based on existing JCA strategy and materials
12 months
12 months
Project
Time to start prior to EMA submission
Duration
Defined activity Ongoing activity, no specific end date
Defined activity
Organization - Asset and portfolio impact assessment
Start date: Q3 '25 | Duration: 3 months
JSC - Strategy development, briefing book and meeting execution
Start date: Q4 '25 | Duration: 6 months
Organization - Ways of working and ownership model development
Start date: Q4 '25 | Duration: 9 months
Other - External stakeholder engagement
Start date: Q2 '26 | Duration: 24 months
Organization - Industry benchmarking and monitoring
Start date: Q2 '26 | Duration: 24 months
Other - Business training delivery
Start date: Q1 '28 | Duration: 1 month
JCA - Early PICO simulation
Start date: Q1 '26 | Duration: 3 months
JCA - Strategy and gap analysis
Start date: Q2 '26 | Duration: 2 months
JCA - Evidence generation planning and execution
Start date: Q3 '26 | Duration: 18 months
JCA - Late PICO simulation
Start date: Q1 '27 | Duration: 3 months
JCA - Dossier development
Start date: Q1 '27 | Duration: 12 months
JCA - In-depth project management
Start date: Q3 '27 | Duration: 6 months
JCA - Post-submission and local HTA coordination
Start date: Q1 '28 | Duration: 3 months
Organization - Asset and portfolio impact assessment
Start date: Q1 '25 | Duration: 3 months
JSC - Strategy development, briefing book and meeting execution
Start date: Q2 '26 | Duration: 6 months
Organization - Ways of working and ownership model development
Start date: Q2 '26 | Duration: 9 months
Other - External stakeholder engagement
Start date: Q4 '26 | Duration: 24 months
Organization - Industry benchmarking and monitoring
Start date: Q4 '26 | Duration: 24 months
Other - Business training delivery
Start date: Q3 '28 | Duration: 1 month
JCA - Early PICO simulation
Start date: Q3 '26 | Duration: 3 months
JCA - Strategy and gap analysis
Start date: Q4 '26 | Duration: 2 months
JCA - Evidence generation planning and execution
Start date: Q4 '26 | Duration: 18 months
JCA - Late PICO simulation
Start date: Q3 '27 | Duration: 3 months
JCA - Dossier development
Start date: Q3 '27 | Duration: 12 months
JCA - In-depth project management
Start date: Q1 '28 | Duration: 6 months
JCA - Post-submission and local HTA coordination
Start date: Q3 '28 | Duration: 3 months
Organization - Asset and portfolio impact assessment
Start date: Q3 '26 | Duration: 3 months
JSC - Strategy development, briefing book and meeting execution
Start date: Q4 '26 | Duration: 6 months
Organization - Ways of working and ownership model development
Start date: Q4 '26 | Duration: 9 months
Other - External stakeholder engagement
Start date: Q2 '27 | Duration: 24 months
Organization - Industry benchmarking and monitoring
Start date: Q2 '27 | Duration: 24 months
Other - Business training delivery
Start date: Q1 '29 | Duration: 1 month
JCA - Early PICO simulation
Start date: Q1 '27 | Duration: 3 months
JCA - Strategy and gap analysis
Start date: Q2 '27 | Duration: 2 months
JCA - Evidence generation planning and execution
Start date: Q3 '27 | Duration: 18 months
JCA - Late PICO simulation
Start date: Q1 '28 | Duration: 3 months
JCA - Dossier development
Start date: Q1 '28 | Duration: 12 months
JCA - In-depth project management
Start date: Q3 '28 | Duration: 6 months
JCA - Post-submission and local HTA coordination
Start date: Q1 '29 | Duration: 3 months
Select your expected EMA filing date for your first orphan asset