Research ArticlePDA Papers
PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492
Emma Ramnarine
Genentech
Ursula Busse
Novartis
Marcello Colao
GlaxoSmithKline Biologicals
Julia Edwards
Biogen
Maik Jornitz
G-Con Manufacturing Inc.
Morten Munk
NNE Pharmaplan
Melissa Seymour
Biogen
Mihaela Simianu
Consultant
Lisa Skeens
Pfizer
Anders Vinther
Sanofi-Pasteur

References
- 1.↵Quality Guideline Q10: Pharmaceutical Quality System. ICH, 2010. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 2016).
- 2.↵ICH Q12 concept paper. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Concept_Paper_July_2014.pdf (accessed August 2016).
- 3.↵ICH Q12 business plan. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Buisness_Plan_July_2014.pdf (accessed August 2016).
- 4.↵Quality Guideline Q8(R2): Pharmaceutical Development. ICH, 2009. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf (accessed August 2016).
- 5.↵Quality Guideline Q9: Quality Risk Management. ICH, 2006. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 2016).
- 6.↵Quality Guideline Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). ICH, 2012. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 2016).
- 7.↵
- Ohage E.,
- Iverson R.,
- Krummen L.,
- Taticek R.,
- Vega M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 163-169; DOI: 10.5731/pdajpst.2016.007492
PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 163-169; DOI: 10.5731/pdajpst.2016.007492
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