Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives

There is growing recognition that the current research-and-development (R&D) and innovation-...

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Clinical Trials in the EU/EEA- Focus on CMC Aspects

Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC. This has...

The Indian Clinical Trial Industry, considered as the booming sector and perceived as a potentially upcoming segment, is undergoing turmoil today with a decline of 9.60 per cent in revenues, with further decline because of delay/decreased clinical trial approvals....

Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news.

Sylvie Le Glédic, Sabah Malek

2013 - SCRIP Regulatory Affairs

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Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid chemistry, manufacturing and control strategy for such products.

Valérie Pimpanneau, Anne Dupraz-Poiseau

2012 - SCRIP Regulatory...

Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and often frail; and the implementation of the Paediatric Regulation in the EU has added a layer of complexity, especially for...

Quality by design (QbD) is becoming increasingly utilized as a valuable tool for focused and efficient drug development. Centering on case studies, we will look at how QbD can be used in its application to small molecules and biopharmaceuticals.

Florence...

Nutritionals & Nutraceuticals describe the group of products occupying the grey zone between food and medicines and having recognisable health and physiological benefits attributable to the efficacy of their consumption. In the more developed markets, these...

Using the voluntary harmonisation procedure to apply for permission to conduct multinational clinical trials across the EU can, in some cases, lead to faster trial authorisations, compared with using the traditional application approach.

Neena Brizmohun,...

Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for biologics and consider the safety, quality and efficacy development challenges for manufacturers.

Anne...

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