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

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…

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…

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…

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)…

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…

AMR: Is a Paradigm Shift Needed in Medicines
Antimicrobial resistance (AMR) is the ability developed by bacteria, viruses, parasites or fungi to fight and block the effect of…

An Advocate of Collaboration : Flora Giorgio Interview
Eric Wery, Vice President Market Access at VCLS conducted an Interview with Flora Georgio, Head of Sector HTA European Commission…

Addressing The Impact of The EU Medical Devices Regulation on Combination Products
An inter-regulatory and stakeholder workshop on combination products, organised by TOPRA and RAPS, was held in Brussels in November 2018.…