VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
Integrating the Paediatric Population within Global Drug Development
By setting mandatory requirements, paediatric regulations implemented in the EU and the US have allowed the development of – and…
The First 10 Years of the European Paediatric Regulation
The conference, organized by TOPRA in collaboration with the European Commission (EC), was the opportunity to hear about the EC’s…
Challenges in Conducting Clinical Trials in Rare Diseases
While individually rare, orphan diseases collectively are actually quite common, with an estimated 350 million sufferers worldwide. Since the introduction…
Advanced Therapy Medicinal Products: An Innovative and Collaborative Approach
Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due…
Overcoming the Challenges of Establishing Expanded Access Programs in European Member States
Early access programs (EAP) provide unauthorized medicinal products prior to marketing authorization and commercial launch for life-threatening, chronically or seriously…
Considerations for Developing EU Risk Management Plans
This article aims to share some key considerations when defining the strategy for the preparation of a risk management plan…
Obtaining Orphan Status – A key milestone within a development strategy
This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US,…
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…