VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications

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…

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…

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…

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…

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…

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…

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…

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…