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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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…
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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.…
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Expedited access of cellular and gene therapy products: The EU versus the US
There is some variation in the eligibility criteria and features of breakthrough therapy designation (BTD), regenerative medicine advanced therapy (RMAT)…
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Brexit: The legal and regulatory impact on supply chain and pharmacovigilance
The UK will withdraw from the EU on 29 March 2019. By 1 August 2018, no agreement had been reached…
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Cell and Gene Therapies: Addressing the Challenges in Translation
Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A…
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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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