VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
publication
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…
publication
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…
publication
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…
publication
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…
publication
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…
publication
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…
publication
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)…
publication
Evolution of the European Regulatory Framework for Innovation – Key Topics for the Future
DIA Europe 2019 was held this year in Vienna, Austria. Speakers included national regulators, together with representatives from health technology…
Resources 