Memento of biomedical research relating to a medicinal product for human use – Laurence Culine

These are books I selected rigorously. It is not necessarily new. They are still current books that I use on a daily basis in my work of clinical research associate and manager. In general, these books have changed my view on biomedical research and the profession of clinical research associate. They allowed me to see more clearly in my profession. They are to be placed in all hands. I will post an article of this type, once a month.

Memento of biomedical research relating to a medicinal product for human use – Laurence Culine – Springer – Year 2012

Laurence Culine is currently Associate Director of the Center of investigations and clinical research in oncology of St Louis and CRC Lariboisière.

For me, this book is a real treat! This is a simple, clear summary of everything to keep in mind about each text of references applicable to biomedical research. It also contains the description and mission of all international and national structures having an impact on biomedical research and pharmacovigilance (CIOMS, ICH, DGS, CNIL, CPP, ISOP, EudraVigilance…). There is even hospitals description and mission, if you find that it is a bit nebulous (PHRC, INSERM, INCA, CNRS, DIRC, DRC, ARH, STIC…).

I enjoyed the schemes for some practical aspects related to promoter, but investigator too.

Personally, I have rarely seen such a complete memento. Whether you are experienced or  beginner CRA, Project Manager or CRA Manager, you will be surprised of what this book can bring to you. This book contains 127 pages and its average cost is 30 euros.

If you are interested in this book you will find it on Amazon, I’ve put a link below.

See you soon,

Vanessa Montanari

Visit also the website of Pharmaspecific, http://www.pharmaspecific.fr and discover our activities.

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