Digital and patient centred innovation in healthcare: Science fiction or tomorrow’s reality?

12 June, 2015 - 1.00 pm CEST

Christophe Amiel, Senior Director, Voisin Consulting Life Sciences, will be a key speaker in conjunction with three other speakers [from Bluemorpho and the Innovative Medicines Initiative (IMI) respectively] presenting a webinar titled, "Digital and patient centred innovation in healthcare: Science fiction or tomorrow’s reality?".

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Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2

June, 2015
Voisin Consulting Life Science - 3, rue des Longs Prés 92100 Boulogne

Submitting a new drug application (NDA) or a biologic license application (BLA) in the US or a marketing authorisation application (MAA) in the EU is the ultimate goal of all sponsors and a mandatory step for the commercialisation of any medicinal products.

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The challenges of potency assay development for cell-based medicinal products in Europe

May, 2015
Voisin Consulting Life Science - 3, rue des Longs Prés 92100 Boulogne

Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products. Potency is considered a critical quality attribute (CQA) for any biological product, and the implementation of relevant assays is often at the centre of many challenges and discussions among developers and regulators throughout product development.

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Keeping up with innovation: The challenge for regulators

March, 2015
Voisin Consulting Life Science - 3, rue des Longs Prés 92100 Boulogne

Big data, mobile and electronic health and synthetic biology are becoming promising drivers for the development of new medicines and medical devices. While these developments increasingly play a part in innovative products that will come to market soon, regulators may not be sufficiently equipped to handle the development and marketing of such novel healthcare products or services.

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