Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management

References

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   1. Ramnarine E.,
   2. Busse U.,
   3. Colao M.,
   4. Edwards J.,
   5. Follman K.,
   6. Gale K.,
   7. Good K.,
   8. Kiani S.,
   9. Jornitz M.,
   10. Munk M.,
   11. O’Donnel K.,
   12. Seymour M.,
   13. Simianu M.,
   14. Skeens L.,
   15. Vinther A.,
   16. Baker D.,
   17. Levy R.

   Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM); Ramnarine E., Busse U., Colao M., Edwards J., Follman K., Gale K., Good K., Kiani S., Jornitz M., Munk M., O’Donnel K., Seymour M., Simianu M., Skeens L., Vinther A., Baker D., Levy R. PDA PAC iAM Survey on Post Approval Changes: Is the Regulatory Environment Hindering Much Need Innovation in the Pharma Industry? PDA J. Pharm. Sci. Technol. 2017, 71 (5), 421–427.

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2. 2.↵
   Economist Intelligence Unit. Medicine and Vaccine Shortages: What Is the Role of Global Regulatory Complexity for Post Approval Changes; EIU, 2018.
3. 3.↵
   Sixty-seventh World Health Assembly. Regulatory System Strengthening for Medical Products; WHA Resolution 67.20; May 2014.
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