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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Update on the Implementation of European ATMP Regulation
A July 2009 adoption/publication of a revised Annex I of Directive 2001/83/EC is foreseen. Discussions on how to appropriately assess…
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Personalized Medicine: From Concept to Reality
As major pharma companies position themselves to market drugs in years to come, they’re seeing fewer blockbuster therapies on the…
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European Biotech Outsourcing on Steep Learning Curve
Demand for contracted services in the European biotech sector is buoyant. As the industry matures and more biotech drug candidates…
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The Implementation of the European Tissues and Cells Directives in France
The main purpose of the tissues and cells directives has been to define a minimum level of quality and standards…
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Pharmacokinetics
As for chemicals, the development of numerous biopharmaceutical products has been accompanied during the last 15 years by a sustained…
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Regulatory Innovative Biomedical Products on Nanotechnology Requires a Combination of Drug and Device Evaluation Expertise
Regulating innovative biomedical products based on nanotechnology requires a combination of drug and device evaluation expertise. Economic forecasts predict the…
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An Insight into the Hearing on Advanced Therapies at the European Parliament
The European Commission issued a proposed regulation in November 2005 on Advanced Therapy Products aiming to provide the much awaited…
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Harmonization Beyond the Implementation of the Clinical Trial Directive
In 1991 the European Commission (EC) initially proposed a clinical trial regulation rather than a directive. Although a regulation typically…
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