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 endorse the responsibility of this type of study. Indeed, “Registries” gather not only observational studies at the initiative of one sponsor but...

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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. To facilitate this process, the EMA has taken a number of initiatives to make clinical data, submitted to support marketing authorisations...

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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. The multiplicity of clinical studies involving ATMPs and more especially GMO products has brought us to focus on the specific...

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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 vitro and animal models to ensure better...

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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 for moving a microbiome product from R&D into first into human studies.

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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 in science and the legitimate expectations of physicians or patients for early access to unauthorised medicinal products prior...

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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 mobile health (m-Health) which is poised to revolutionize sectors of healthcare. The rapid pace of growth in m-...

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