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19th Annual Drug Information Association (DIA) EuroMeeting

26–28 March 2007; Vienna, Austria

  • Meeting Report
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Notes

  1. Medicines for rare disorders are commonly called ‘orphan drugs’; further information can be found at http://www.fda.gov/orphan/index.htm.

  2. Further information on paediatric medicines can be found on the CDER website at http://www.fda.gov/cder/pediatric/index.htm.

  3. The use of trade names is for product identification purposes only and does not imply endorsement.

  4. A ‘bridging’ study is defined as a study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety and dose regimen in the new region that will allow extrapolation of the foreign data to the population in the new region.

  5. Information from Dr Terry Winters, Chairman and CEO, Vital Therapies, Inc., San Diego, CA, USA (www.vitaltherapies.com).

References

  1. The European Medicines Agency. The European Medicines Agency road map to 2010: preparing the ground for the future. EMEA/H/34163/03/Final [online]. Available from URL: http://www.emea.europa.eu/htms/general/direct/roadmap/roadmapintro.htm [Accessed 2007 Jun 5]

    Google Scholar 

  2. The European Medicines Agency. Status report on the implementation of the EMEA road map. 2006 May 10. EMEA/171321/2006 [online]. Available from URL: http://www.emea.europa.eu/pdfs/general/direct/directory/17132106en.pdf [Accessed 2007 Jul 2]

    Google Scholar 

  3. European risk management strategy: progress to date and next steps [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/phv/13625305en.pdf [Accessed 2007 Jul 2]

  4. US Department of Health and Human Service, Food and Drug Administration. Challenge and opportunity on the critical path to new medicinal products [online]. Available from URL: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html [Accessed 2007 Jun 5]

    Google Scholar 

  5. Committee for Medicinal Products for Human Use. Guideline on clinical trials in small populations. CHMP/EWP/83561/2005 [online]. Available from URL: http://www.emea.eu.int/pdfs/human/ewp/8356105en.pdf [Accessed 2007 Apr 27]

    Google Scholar 

  6. European Medicines Agency. Reflection paper on methodological issues in confirmatory clinical trials with flexible designs and analysis plans. CHMP/EWP/ 2459/02 [online]. Available from URL: http://www.emea.eu.int/pdfs/human/ewp/245902en.pdf [Accessed 2007 Apr 27]

    Google Scholar 

  7. Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Reg (EC) 726/2004 [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/review/doc/final_publ/reg_2004_726_20040430_en.pdf [Accessed 2007 Apr 27]

    Google Scholar 

  8. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the clinical investigation of plasma derived antithrombin products. CPMP/BPWG/ 2220/99 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/bpwg/222099en.pdf [Accessed 2007 Apr 27]

    Google Scholar 

  9. Pharmaceuticals and Medical Devices Agency. Clinical Trial Issue Review Committee: the interim report [online]. Available from URL: http://www.pmda.go.jp/english/topics/pdf/clinical.pdf [Accessed 2007 Jun 6]

    Google Scholar 

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Acknowledgements

Dr Kitler is a consultant at Associates for Business and Research (ABR), which specialises in all issues relating to the pharmaceutical and biotechnology industry. She can be contacted at fredfifijdk@yahoo.com; phone +41 21 824 1419.

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Kitler, M.E. 19th Annual Drug Information Association (DIA) EuroMeeting. Int J Pharm Med 21, 287–294 (2007). https://doi.org/10.2165/00124363-200721040-00005

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