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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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)…
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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…
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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…
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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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