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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General Data Protection Regulation and Patients Enrolled in EU Clinical Trials
Processing and cross-border flows of personal data significantly increased over the past decades in the EU, and it became necessary…
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Clinical Trials with GMOs in the EU – From Regulatory to Sites
Clinical trials (CTs) with investigational medicinal products (IMPs) that contain or consist of genetically modified organism(s) (GMO-IMPs) have significantly increased…
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Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs,…
The added value of in silico models (including quantitative systems pharmacology models) for drug development is now unanimously recognized. It…
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A Regulatory Landscape Shift for In Silico Clinical Trials
Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to…
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Cell and Gene therapies: European View on Challenges in Translation and How to Address Them
Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A…
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Recent Revisions to Legislation Impacting the Pharmaceutical Industry in Switzerland
With the objective of harmonizing pharmaceutical regulatory practices and legislation with Europe, the Swiss Medicines Agency (Swissmedic) recently conducted an…
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EU Cooperation on Health Technology Assessment and Beyond
An informative session at this year’s DIA meeting gave an overview of the European Commission’s proposal for mandatory centralization of…
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Optimising the Choice of the Condition for a Paediatric Investigation Plan
The “Condition” is typically a recognised distinct disease or syndrome that is the subject of a paediatric investigation plan (PIP)…
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