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
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
Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new…
For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis…
publication
Impact of the New Pharmaceutical Legislation on the Development and Registration of Biological Medicinal Products…
This article reviews the impact of the new pharmaceutical legislation on the development of biotech products. The authors describe in…
publication
Consulting with EU experts Why, When & How
Despite the increasing range of guidance documents available, and the best efforts of those involved in producing them, product development…
presentation
Impact on regulatory Framework for Clinical Trial Applications within the European Union
Impact on regulatory Framework for Clinical Trial Applications within the European Union from Voisin Consulting Life Sciences The current regulatory…
presentation
Overview of EU Regulatory Landscape for Regenerative Medicines
Regenerative medicines, part of the so-called Advanced Therapy Medicinal Products (ATMPs) in Europe, are cell-based medicinal products aiming at replacing…
whitepaper
Public Access to Clinical Data: The evolution of initiatives from the European Medicines Agency
It remains the mission of all stakeholders to get high quality medicines to patients as time- and cost-efficiently as possible.…
