While the PQS is applicable from development through product discontinuation, certain elements of the PQS become more or less relevant over the lifecycle. The principles of Quality by Design can be embraced during the development to assure a product, including the processes used to manufacture and test the product can be successfully commercialised.
This session will look at approaches for applying the elements and the tools of the PQS into development of drug substance and drug product with the goal of smooth technology transfer into commercial launch. Moreover, this session will look at lessons learned through commercialisation and post market surveillance to effect continuous improvement of the product.
|Tuesday 15 November 2011|
|08:00||08:25||Designing and Developing Products to Meet Patient Needs under PQS
Keith Pugh, Medicines and Healthcare Products Regulatory Agency (MHRA)
|08:25||08:50||Q10 Approach to Design
Georges France, Pfizer
George Millili, Merck & Co. Inc.
|09:15||09:40||Case Study: Commercial Manufacturing
Kevin O'Donnell, Irish Medicines Board (IMB)
Georges France, Pfizer; George Millili, Merck & Co. Inc.; Kevin O'Donnell, IMB; Keith Pugh, (MHRA)
|Monday 14 November 2011||Tuesday 15 November 2011||Wednesday 16 November 2011|
Plenary Session 1 & 2:
Plenary Sessions 3 & 4:
Plenary Session 5:
Plenary Session 6:
Plenary Session 7:
Plenary Session 9:
Plenary Session 10:
Plenary Session 11:
|Monday 14 November 2011|
|Exhibition Networking Reception|