Latest Whitepapers
whitepaper
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…
whitepaper
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…
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.…
whitepaper
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.…
whitepaper
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…
whitepaper
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…
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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…
whitepaper
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…
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