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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US & EU Regulations for Drug Delivery Systems: development considerations for innovate products
Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for…
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Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new…
For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis…
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Biomarkers qualifications: a first step towards companion diagnostic development
Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification…
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Considerations on Pediatric Investigation Plans (PIP) for Advanced Therapy Medicinal Products
In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company…
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Telemedecine and e-Health Systems
A long-standing challenge for regulators has been how to incorporate new technologies into the current regulatory framework. This is especially…
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Activities to improve the regulatory framework for companion diagnostics step up
Personalised medicine aims to provide the right treatment to the right patient, at the right dose and at the right…
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How to optimally integrate a Paediatric Investigation Plan into a drug development programs
For products falling under the mandatory scope of the centralised procedure, integrating a Paediatric Investigation Plan (PIP) into a company’s…
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EU Compassionate Use Programme (CUP) Regulatory Framework and Points to Consider Before CUP Implementation
For some patients, compassionate use programmes (CUPs) are the only way to access promising medicinal products that are not yet…
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