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La preparazione di un Investigational Medicinal Product Dossier (IMPD)

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Sperimentazione e registrazione dei radiofarmaci

Part of the book series: Imaging & Formazione ((IMAG))

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Riassunto

Al fine di armonizzare le procedure di autorizzazione, l’EMA sollecita tutte le Autorità competenti (AC) degli Stati membri (SM) a utilizzare modulistiche per la presentazione e la valutazione della documentazione il più possibile analoghe a quelle usate per le procedure centralizzate. Il dossier del farmaco sperimentale (IMP, Investigational Medicinal Product), chiamato IMPD (Investigational Medicinal Product Dossier), ricalca infatti il CTD (Common Technical Document) utilizzato per la registrazione dei medicinali.

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Bibliografia

  1. Decreto del Ministro della Salute 21 dicembre 2007 Modalità di inoltro della richiesta di autorizzazione all’Autorità competente, per la comunicazione di emendamenti sostanziali e la dichiarazione di conclusione della sperimentazione clinica e per la richiesta di parere al comitato etico

    Google Scholar 

  2. Decreto Legislativo 24 giugno 2003, n. 211, Attuazione della direttiva 2001/20/CE relativa all’applicazione della buona pratica clinica nell’esecuzione delle sperimentazioni cliniche di medicinali per uso clinico

    Google Scholar 

  3. Decreto Legislativo 6 novembre 2007, n. 200, Attuazione della direttiva 2005/28/CE recante principi e linee guida dettagliate per la buona pratica clinica relativa ai medicinali in fase di sperimentazione a uso umano, nonché requisiti per l’autorizzazione alla fabbricazione o importazione di tali medicinali

    Google Scholar 

  4. Decreto Legislativo 2 marzo 2007, n. 50, Attuazione delle direttive 2004/9/CE e 2004/10/CE, concernenti l’ispezione e la verifica della buona pratica di laboratorio (BPL) e il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative relative all’applicazione dei principi di buona pratica di laboratorio e al controllo della loro applicazione per le prove sulle sostanze chimiche

    Google Scholar 

  5. Ministero della Salute — Buona pratica di laboratorio http://www.salute.gov.it/buonaPraticaLaboratorio/ buonaPraticaLaboratorio.jsp

    Google Scholar 

  6. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Guide-line on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials, CHMP/QWP/185401/2004 final http://www. ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003484

    Google Scholar 

  7. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Guide-line on radiopharmaceuticals EMEA/CHMP/QWP/306970/2007 http://www.ema.europa.eu/ema/ pages/includes/document/open_document.jsp?webContentId=WC500003538

    Google Scholar 

  8. European Medicines Agency ICH Topic Q2 (R1) Validation of analytical procedures: text and methodology, CPMP/ICH/381/95 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500002662.pdf

    Google Scholar 

  9. European Medicines Agency, Evaluation of Medicines for Human Use — Committee For Medicinal Products For Human Use (CHMP) Guideline on the limits of genotoxic impurities, EMEA/ CHMP/QWP/251344/2006 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500002903.pdf

    Google Scholar 

  10. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Questions and answers on the Guideline on the limits of genotoxic impurities EMA/CHMP/SWP/431994/2007 Rev. 3 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/ WC500002907.pdf

    Google Scholar 

  11. European Medicines Agency, ICH Stability Guidelines Topic Q1 http://www.ema.europa.eu/ema/ index.jsp?curl=pages/regulation/general/general_content_000431.jsp&murl=menus/regulations/ regulations.jsp&mid=WC0b01ac0580029593&jsenabled=true#Stability

    Google Scholar 

  12. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Annex II to Note for guidance on process validation CHMP/QWP/848/99 and EMEA/CVMP/598/99 Non Standard Processes CPMP/QWP/2054/03 http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2009/09/WC500002914.pdf

    Google Scholar 

  13. European Commission, Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev 3) http:// eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:073:0001:0018:en:pdf

    Google Scholar 

  14. European Medicines Agency, ICH Specifications Guidelines Topic Q6 http://www.ema.europa.eu/ ema/index.jsp?curl=pages/regulation/general/general_content_000431.jsp&murl=menus/regulations/ regulations.jsp&mid=WC0b01ac0580029593&jsenabled=true#Specifications

    Google Scholar 

  15. GB/document_library/Scientific_guideline/2009/09/WC500002720.pdf

    Google Scholar 

  16. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) ICH guideline S6 (R1) — Preclinical Safety evaluation of biotechnology-derived pharmaceuticals CPMP/ICH/731268/1998 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500002828.pdf

    Google Scholar 

  17. European Medicines Agency, Radiopharmaceuticals 3AQ20a http://www.ema.europa.eu/docs/ en_GB/document_library/Scientific_guideline/2009/09/WC500003653.pdf

    Google Scholar 

  18. European Medicines Agency, Radiopharmaceuticals based on monoclonal antibodies 3AQ21a http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003 666.pdf

    Google Scholar 

  19. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Guide-line on radiopharmaceuticals EMEA/CHMP/QWP/306970/2007 http://www.ema.europa.eu/docs/ en_GB/document_library/Scientific_guideline/2009/09/WC500003549.pdf

    Google Scholar 

  20. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Guide-line on production and quality control of monoclonal antibodies and related substances EMEA/ CHMP/BWP/157653/2007 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500003073.pdf

    Google Scholar 

  21. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Guide-line on clinical evaluation of diagnostic agents CPMP/EWP/1119/98/ Rev 1 2008 http://www.ema. europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003580.pdf

    Google Scholar 

  22. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Appendix 1 to the guideline CPMP/EWP/1119/98 Rev. 1 On Imaging Agents EMEA/CHMP/EWP/ 321180/2008 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/ 09/WC500003581.pdf

    Google Scholar 

  23. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Guide-line on core SmPC and Package Leaflet for Radiopharmaceuticals EMA/CHMP/167834/2011 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/10/WC50011 5503.pdf

    Google Scholar 

  24. European Medicines Agency — Committee For Medicinal Products For Human Use (CHMP) Concept paper on the harmonisation and update of the clinical aspects in the authorised conditions of use for radiopharmaceuticals and other diagnostic medicinal products EMEA/CHMP/EWP/12052/2008 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC5000035 82.pdf

    Google Scholar 

  25. Direttiva 2001/20/CE del Parlamento europeo e del Consiglio del 4 aprile 2001 concernente il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative degli Stati membri relative all’applicazione della buona pratica clinica nell’esecuzione della sperimentazione clinica di medicinali ad uso umano

    Google Scholar 

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Authors
  1. I. Sestili
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  2. G. Gostoli
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  3. F. Fabi
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  4. M. F. Cometa
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Editor information

Editors and Affiliations

  1. Dipartimento di Scienze della Salute, Università degli Studi di Milano, Italy

    Giovanni Lucignani

  2. UO Medicina Nucleare e Dipartimento dei Servizi Diagnostici, Azienda Ospedaliera San Paolo, Milano, Italy

    Giovanni Lucignani

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Sestili, I., Gostoli, G., Fabi, F., Cometa, M.F. (2013). La preparazione di un Investigational Medicinal Product Dossier (IMPD). In: Lucignani, G. (eds) Sperimentazione e registrazione dei radiofarmaci. Imaging & Formazione. Springer, Milano. https://doi.org/10.1007/978-88-470-2874-6_10

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  • DOI: https://doi.org/10.1007/978-88-470-2874-6_10

  • Publisher Name: Springer, Milano

  • Print ISBN: 978-88-470-2873-9

  • Online ISBN: 978-88-470-2874-6

  • eBook Packages: MedicineMedicine (R0)

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