VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
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CMC considerations for US biosimilars development
The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products.…
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IVDR Readiness Checklist
In the blog post “IVD Directive to IVD Regulation Transition – 8 months remaining”, my colleague outlined some key focus…
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Possible Contexts of Use for In Silico trials methodologies: a consensus-based review
The term “In Silico Trial” indicates the use of computer modelling and simulation to evaluate the safety and efficacy of…
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Advanced therapies in the EU: challenges with HTA and real-world evidence
Market access aims to make a health technology not only available and affordable for every patient, but also profitable for…
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Driving the Healthcare Regulatory System Into the Future
This is a summary report on the panel discussion at the TOPRA Symposium 2020. The panel discussed how the EMA…
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TOPRA/RAPS Workshop on Alignment of Global Combination Products
The TOPRA/RAPS inter-regulatory and stakeholder two-day workshop held in June 2020 focused on global combination product regulations. The diverse panel…
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Incorporating patients’ voices in the drug development process
Our Senior Director, Mike Day recently interviewed Robyn Bent, Director, CDER PFDD Program, Center for Drug Evaluation and Research, US…
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Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy
This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding…
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