Eugenie van Lieshout
Regulatory Affairs Lead, Johnson & Johnson
Eugenie van serves as the Regulatory Affairs Lead for Johnson & Johnson in The Netherlands, where she plays a crucial role in navigating the complex regulatory landscape. Passionate about regulatory affairs, she is committed to innovating the profession and ensuring timely access to healthcare solutions.
As the Chair of the Regulatory Affairs group for the Dutch Trade Association VIG, Eugenie unites industry professionals to address regulatory challenges effectively. Furthermore, her influence extends to the Board of the professional association NVFG RegNed, where she advocates for best practices in regulatory affairs.
With a solid background as a Global Clinical Research Scientist and Global Regulatory Lead at renowned pharmaceutical companies like Organon and MSD, Eugenie brings extensive experience to her current role. Her expertise helps drive regulatory strategies that emphasize patient access and safety.
Today, she is set to speak on Early Access, highlighting her dedication to advancing innovative approaches within the regulatory realm. With her leadership and vision, Eugenie continues to significantly contribute to the future of healthcare in her community and beyond.
Presentation: Navigating Compassionate Use in the Netherlands: Opportunities and Challenges from a company perspective
In her presentation, Eugenie van Lieshout, Lead Regulatory Affairs NL at Johnson & Johnson, explores the critical role of compassionate use programs in providing patients with serious or life-threatening conditions access to innovative medicines. She highlights the various pathways available in the Netherlands, including off-label use, doctor’s declaration and clinical trials, emphasizing the importance of early access programs managed by J&J on a global level.
Eugenie discusses the criteria for early access, such as unmet medical need and the scientific evidence required to demonstrate benefits outweighing risks. She also elaborates on the steps J&J takes to initiate early access in the Netherlands and addresses the challenges posed by Europe's heterogenic pathways and data collection complexities.
This presentation underscores the importance of collaboration among healthcare providers, regulators, and pharmaceutical companies to ensure timely access to promising therapies while maintaining patient safety and regulatory compliance.
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