VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
publication
Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps
This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to…
publication
The Challenges of Potency Assay Development for Cell-based Medicinal Products in Europe
Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature…
publication
Preparing a Drug Registration for the US and the EU Parallel or sequential applications –…
This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the…
publication
Keeping Up with Innovation The challenge for regulators
Big data, mobile health and synthetic biology: An overview of some of the changes and measures were taken by regulators…
publication
Modern Technology Transfer Strategies for Biopharmaceutical Companies
Application of industrial biotechnology has changed dramatically over the past decade. Stainless steel process equipment has largely given way to…
publication
Preparing a Drug Registration for the US and the EU: Parallel or sequential applications? –…
An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region…
publication
Regulatory Approval and Market Access: a winning combination for drug launch optimization
Having a combined regulatory and market access strategy is critical for a drug launch to be successful. Marcus Deans, Mark…
publication
Accelerating development, registration and access to medicines for rare diseases in the European Union through…
Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives…
Resources 