VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
![Post thumbnail Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/09/Publication-Image-233x260.png)
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…
![Post thumbnail General Data Protection Regulation and Patients Enrolled in EU Clinical Trials](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/08/General-Data-Protection-Regulation-233x260.jpg)
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…
![Post thumbnail Clinical Trials with GMOs in the EU – From Regulatory to Sites](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/06/Clinical-Trials-GMO-233x260.jpg)
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…
![Post thumbnail Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/04/Verifying-and-Validating-Quantitative-Systems-Pharmacology-and-In-Silico-Models-in-Drug-Development-233x260.jpg)
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…
![Post thumbnail A Regulatory Landscape Shift for In Silico Clinical Trials](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/01/Insilico-233x260.jpg)
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…
![Post thumbnail Cell and Gene therapies: European View on Challenges in Translation and How to Address Them](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/ATMP-233x260.jpg)
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…
![Post thumbnail Recent Revisions to Legislation Impacting the Pharmaceutical Industry in Switzerland](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/10/the-pharmaceutical-industry-in-Swiss-233x260.jpg)
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…
![Post thumbnail EU Cooperation on Health Technology Assessment and Beyond](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/shutterstock_1406304326-233x260.jpg)
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…