Latest Whitepapers
![Post thumbnail Are Registries the New “Gold Standard” ?](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/shutterstock_1033451641-e1574691981864-233x260.jpg)
Are Registries the New “Gold Standard” ?
There are multiple definitions associated with a registry and any future sponsors can feel anxious when it is time to…
![Post thumbnail Are Registries the New “Gold Standard” ?](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/shutterstock_1033451641-e1574691981864-233x260.jpg)
Are Registries the New “Gold Standard” ?
There are multiple definitions associated with a registry and any future sponsors can feel anxious when it is time to…
![Post thumbnail Public Access to Clinical Data: The evolution of initiatives from the European Medicines Agency](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/Medical-Writing_shutterstock_571935643_web-233x260.jpg)
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.…
![Post thumbnail Clinical trials with ATMPs in Europe: a focus on GMO specificities](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/voisin-consulting_cell-and-gene-therapy-233x260.jpg)
Clinical trials with ATMPs in Europe: a focus on GMO specificities
Advanced Therapy Medicinal Products (ATMPs) are an innovative type of medicines for human use, based on genes, cells or tissues.…
![Post thumbnail In Silico Approach: from computer to patient ?](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/atomsz-233x260.png)
In Silico Approach: from computer to patient ?
Until recently, all pharmacology characterization was involving in vitro and in vivo studies. Important efforts arebeing made to refine in…
![Post thumbnail Overcoming Regulatory and CMC Technical Challenges of Microbiome Product Development](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/201707_whitepaper_CMC-Microbiome-233x260.png)
Overcoming Regulatory and CMC Technical Challenges of Microbiome Product Development
In this white paper we provide a fleeting look at some of the CMC ‘building blocks’ that can be assembled…
![Post thumbnail Early Access Programmes / Compassionate Use Programmes: How to effectively deal with the challenges](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/achieve_700x425-233x260.jpg)
Early Access Programmes / Compassionate Use Programmes: How to effectively deal with the challenges
Early access programmes (sometimes also called compassionate use or temporary use authorisation) were set up because of the rapid advances…
![Post thumbnail Navigating the Maze of m-Health Regulation and Development](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2019/11/mobile-application_700x425-233x260.jpg)
Navigating the Maze of m-Health Regulation and Development
The widespread adoption of mobile and wireless technologies, including smartphones and tablets, has given rise to the growing field of…