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Thoughtful Testing

 

The European Medicines Agency (EMEA) is a decentralised body of the EU. Its main responsibility is the safety and promotion of public health, through the evaluation and supervision of medicines for human use. The EMEA holds responsibility for the scientific evaluation of applications for European marketing authorisation of medicinal products (1).

NEW GUIDELINES

On 1st February 2009, the EMEA released new guidelines for companies developing medicines for the treatment of Alzheimerís disease (AD) and other dementias, and for Parkinsonís disease, in the light of recent scientific progression in the understanding of these diseases and conditions (2). The document itself is offered as general guidance on the development of medicinal products for the treatment of dementia and its subtypes. It does not replace other EMEA and ICH guidelines, but rather works in collaboration with them.

The advances over the past few years in both clinical science and molecular biology have contributed to an emphasis on and growing interest in the development of more valuable symptomatic or disease-modifying treatments, such as early treatments that could prevent the emergence or even slow the progression of a disease. These guidelines have been developed to assist companies developing such medicines on appropriate clinical trial designs (2).


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Helen Brooker began working for CDR Ltd in March 2008 and is an active member of the R&D team. She graduated with a first class honours degree in 2006 and went on to be involved in numerous research projects. She is currently embarking on her MSc in Psychology. Helen is the R&D project manger and manages the CDR Collaborative Research programme, where she works with key medical institutions and universities across the globe. She works closely with the expanding scientific development team as well as providing scientific support to business development.

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