Inkatuuli Heikkinen | Maastricht School of Management (original) (raw)

Inkatuuli Heikkinen

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Papers by Inkatuuli Heikkinen

Research paper thumbnail of Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective

Research paper thumbnail of Acceptance of stakeholder comments during EMA scientific guidelines public consultations: legitimacy of the quadruple helix model of innovation

Aim: Guidelines establish a framework for how therapeutics and vaccines are developed, assessed a... more Aim: Guidelines establish a framework for how therapeutics and vaccines are developed, assessed and approved. They influence which innovations are likely to be approved in the EU, and by that, they have an impact on the pipeline decisions taken by the research-based industry. This study analyses the level of acceptance for changes suggested by stakeholders within the authoring groups at the EMA. Methods: We looked at 87 guidelines from EMA Working Parties (WPs) launched for consultation between 2013-2017. Acceptance of stakeholder proposals and the time between the end of consultation and guideline adoption were studied as well as the openness of different Working Parties to accept changes. Results: Adoption of a guideline after the close of public consultation took at least 4 months, with average 12-16 months. The number of accepted and rejected comments were nearly equal across the stakeholders, with government having slightly higher chance for acceptance. Academia and NGOs had ge...

Research paper thumbnail of Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions

Research paper thumbnail of Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective

Research paper thumbnail of Acceptance of stakeholder comments during EMA scientific guidelines public consultations: legitimacy of the quadruple helix model of innovation

Aim: Guidelines establish a framework for how therapeutics and vaccines are developed, assessed a... more Aim: Guidelines establish a framework for how therapeutics and vaccines are developed, assessed and approved. They influence which innovations are likely to be approved in the EU, and by that, they have an impact on the pipeline decisions taken by the research-based industry. This study analyses the level of acceptance for changes suggested by stakeholders within the authoring groups at the EMA. Methods: We looked at 87 guidelines from EMA Working Parties (WPs) launched for consultation between 2013-2017. Acceptance of stakeholder proposals and the time between the end of consultation and guideline adoption were studied as well as the openness of different Working Parties to accept changes. Results: Adoption of a guideline after the close of public consultation took at least 4 months, with average 12-16 months. The number of accepted and rejected comments were nearly equal across the stakeholders, with government having slightly higher chance for acceptance. Academia and NGOs had ge...

Research paper thumbnail of Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions

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