VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
![Post thumbnail Regulatory Trends in the Nonclinical Development of Viral Vector-Based Gene Therapies: A Benchmark Analysis of Approved Products](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/06/shutterstock_2033048417-233x260.jpg)
Regulatory Trends in the Nonclinical Development of Viral Vector-Based Gene Therapies: A Benchmark Analysis of…
As it is often the case with innovative technologies, regulatory agencies are highly demanding in product safety demonstration from those…
![Post thumbnail CMC considerations for US biosimilars development](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2022/04/manufacturer-of-biosimilars-233x260.jpg)
CMC considerations for US biosimilars development
The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products.…
![Post thumbnail IVDR Readiness Checklist](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2021/09/EU-IVDR-233x260.jpg)
IVDR Readiness Checklist
In the blog post “IVD Directive to IVD Regulation Transition – 8 months remaining”, my colleague outlined some key focus…
![Post thumbnail Possible Contexts of Use for In Silico trials methodologies: a consensus-based review](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2021/06/shutterstock_790481860-233x260.jpg)
Possible Contexts of Use for In Silico trials methodologies: a consensus-based review
The term “In Silico Trial” indicates the use of computer modelling and simulation to evaluate the safety and efficacy of…
![Post thumbnail Advanced therapies in the EU: challenges with HTA and real-world evidence](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2021/06/shutterstock_279505526-233x260.jpg)
Advanced therapies in the EU: challenges with HTA and real-world evidence
Market access aims to make a health technology not only available and affordable for every patient, but also profitable for…
![Post thumbnail Driving the Healthcare Regulatory System Into the Future](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/11/EMA-and-national-regulatory-agencies-1-233x260.png)
Driving the Healthcare Regulatory System Into the Future
This is a summary report on the panel discussion at the TOPRA Symposium 2020. The panel discussed how the EMA…
![Post thumbnail TOPRA/RAPS Workshop on Alignment of Global Combination Products](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/11/Combination-Products-233x260.jpg)
TOPRA/RAPS Workshop on Alignment of Global Combination Products
The TOPRA/RAPS inter-regulatory and stakeholder two-day workshop held in June 2020 focused on global combination product regulations. The diverse panel…
![Post thumbnail Incorporating patients’ voices in the drug development process](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2020/09/FDA-Interview-V4-233x260.png)
Incorporating patients’ voices in the drug development process
Our Senior Director, Mike Day recently interviewed Robyn Bent, Director, CDER PFDD Program, Center for Drug Evaluation and Research, US…