VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
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Market Access for ATMPs Begins at the Bench
Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing…
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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…
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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…
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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…
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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…
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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…
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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…
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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,…
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