Zilke Claessens
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View article: Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews
Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews Open
Introduction During the COVID-19 pandemic, regulatory and market access actions were taken to expedite the market entry of COVID-19 medicines. This study aims to (i) capture multi-stakeholder views on these actions, and (ii) provide recomm…
View article: Unmet health-related needs of heritable arrhythmogenic cardiomyopathy carriers in Belgium: The UR-HEART survey study
Unmet health-related needs of heritable arrhythmogenic cardiomyopathy carriers in Belgium: The UR-HEART survey study Open
View article: Criteria to evaluate unmet health-related needs of persons living with rare diseases and their caregivers: rapid literature review and stakeholder consultations
Criteria to evaluate unmet health-related needs of persons living with rare diseases and their caregivers: rapid literature review and stakeholder consultations Open
Background Rare diseases affect small populations but present unique challenges in access to healthcare and social support. The needs of patients and their caregivers extend beyond medical treatments, impacting various aspects of their liv…
View article: Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation
Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation Open
Introduction The 2020 pharmaceutical strategy for Europe stressed that rethinking regulatory policies to foster innovation in disease areas with unmet medical needs (UMN) is one of the European Commission’s (EC) priority areas. To understa…
View article: Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020
Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020 Open
Background At the European level, several regulatory measures (ie, priority medicines (PRIME) scheme, accelerated assessment, conditional marketing authorisation and authorisation under exceptional circumstances) are in place with the aim …
View article: Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative Open
National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria,…
View article: Needs and challenges among general practitioners in the management of actinic keratosis: a qualitative study
Needs and challenges among general practitioners in the management of actinic keratosis: a qualitative study Open
Background Because of the increasing incidence of actinic keratosis (AK), optimal use of limited healthcare resources is essential. Although most patients can be managed in primary care, dermatology referrals are common. More profound know…
View article: How to balance valuable innovation with affordable access to medicines in Belgium?
How to balance valuable innovation with affordable access to medicines in Belgium? Open
Background: Countries are struggling to provide affordable access to medicines while supporting the market entry of innovative, expensive products. This Perspective aims to discuss challenges and avenues for balancing health care system ob…