Leading the Advance in Regulatory Science

  • Nuala CalnanEmail author


That the pharmaceutical industry is undergoing a period of great transformation can be in little doubt, with so many industry reports highlighting the magnitude of the impact of the patent cliff on big pharma revenues and share prices.


European Medicine Agency Quality Management System Drug Shortage Supply Chain Security Overall Equipment Effectiveness 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. (2001) Parliament E Article 111(6) of directive 2001/83/EC. (EC), E. C., EdGoogle Scholar
  2. (2013) EudraGMP, EudraGMDP _European medicines agency on-line database for MIA’s and GMP certs. EMAGoogle Scholar
  3. Center EYGLS (2013) Closing the gap? Big pharma’s growth challenge and implications for deals. JanuaryGoogle Scholar
  4. Deloitte (2013) Global life sciences outlook ‘optimism tempered by reality in a “new normal”’Google Scholar
  5. Deming WE (2000) Out of the crisis. 1st MIT Press edn. MIT Press, Cambridge, p xiii, 507 pGoogle Scholar
  6. EMA (2012a) Reflection paper on medicinal product supply shortages caused by manufacturing/good manufacturing practice compliance problems. Nov 2012Google Scholar
  7. EMA (2012b) Guideline on process validation-draft. Agency, E. M., Ed. March 2012Google Scholar
  8. FDA (2011a) A review of FDA’s approach to medical product shortages. October 2011.Google Scholar
  9. FDA (2011b) Guidance for industry, process validation: general principles and practices. Current Good Manufacturing Practices (CGMP) revision 1 edn. FDA Ed. January 2011, p 19Google Scholar
  10. FDA (2011c) Advancing regulatory science at FDA: a strategic plan; August 2011Google Scholar
  11. FiercePharma (2013) Top 15 drug patent losses for 2013. Nov 2012
  12. Friedli T (2012) Mastering plant complexity and the impact of operational excellence. In: global pharma manufacturing summit. New JerseyGoogle Scholar
  13. Grady Denise PA, Tavernise Sabrina (2012) Scant oversight of drug maker in fatal meningitis outbreak. Wall Street J. 06 Oct 2012Google Scholar
  14. ICH Q-IWG (2012) Introduction to ICH and the new quality paradigm. In: Robert JL (ed) Integrated training programme. ICH, Washington, DCGoogle Scholar
  15. ICH (2008) ICH harmonised tripartite guideline: pharmaceutical quality system Q10. ICH, Ed. June 2008Google Scholar
  16. ICH (2009a) ICH harmonised tripartite guideline: pharmaceutical development Q8(R2). ICH, Ed. Aug 2009Google Scholar
  17. ICH (2009b) ICH harmonised tripartite guideline: quality risk management Q9. ICH, Ed. Nov 2009Google Scholar
  18. ICH (2012) Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) Q11. ICH. 1 May 2012Google Scholar
  19. Margaret A, Hamburg MD (2013a) Weaving new threads in FDA’s global safety net. FDA. 22 Feb 2013Google Scholar
  20. Margaret A, Hamburg MD (2013) Address to the annual meeting generic pharmaceutical manufacturers association on the prioritization of product quality. FDA. 22 Feb 2013Google Scholar
  21. McLaughlin T (2012) New England compounding center, pharmacy linked to meningitis outbreak, files for bankruptcy. Huffington Post 21 Dec 2012Google Scholar
  22. News C (2013) Lethal medicine linked to meningitis outbreak. 10 Mar 2013Google Scholar
  23. Nonaka Ikujiro NT Knowledge emergence. Oxford University Press.Google Scholar
  24. Nonaka I, Toyama R, Konno N (2000) SECI, Ba and leadership: a unified model of dynamic knowledge creation. Long Range Plann 33:5–34CrossRefGoogle Scholar
  25. O’Donnell K, Irish Medicines Board (IMB) (2012) Quality defect and product recall statistics, 2004–2011. IMB ‘Industry Open Day’ seminar 2012, 27 Sept 2012Google Scholar
  26. ShaAvhrée Buckman-Garner M (2013) How FDA promotes partnerships to accelerate medical product development. FDAGoogle Scholar
  27. Skibo AR (2013) Outsourcing & emerging markets v’s quality and drug availability. In: Creating, implementing and sustaining a culture of quality-putting the c into cGMP. ISPE, BaltimoreGoogle Scholar
  28. Transfer Center for Technology Management (2012) U. o. S. G. operational excellence in the pharmaceutical industry. Accessed Dec 2012
  29. Woodcock J (2012) Reliable drug quality: an unresolved problem. J Pharm Sci Technol 66(3):270–272Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Dublin Institute of Technology (DIT)DublinIreland

Personalised recommendations