EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)

Author:

Todde Sergio,Windhorst Albert D.,Behe Martin,Bormans Guy,Decristoforo Clemens,Faivre-Chauvet Alain,Ferrari Valentina,Gee Antony D.,Gulyas Balazs,Halldin Christer,Peitl Petra Kolenc,Koziorowski Jacek,Mindt Thomas L.,Sollini Martina,Vercouillie Johnny,Ballinger James R.,Elsinga Philip H.

Publisher

Springer Science and Business Media LLC

Subject

Radiology, Nuclear Medicine and imaging,General Medicine,Radiology, Nuclear Medicine and imaging,General Medicine

Reference15 articles.

1. European Association of Nuclear Medicine Radiopharmacy Committee. Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals, version 2, 2007. http://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf . Accessed 11 July 2014.

2. Elsinga P, Todde S, Penuelas I, Meyer G, Farstad B, Faivre-Chauvet A, et al. Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. Eur J Nucl Med Mol Imaging 2010;37:1049–62.

3. European Parliament and the Council of the European Union. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Union 2001;L(121):34–44.

4. European Parliament and Council of the European Union. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Off J Eur Union 2014;L(158):1–76.

5. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on the requirements for quality documentation concerning investigational medicinal products in clinical trials. 2012. EMA/CHMP/BWP/534898/2008.

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