Pharmaceutical Quality System
Plenary Session 1
Moderator:David Cockburn, European Medicines Agency (EMA)
Why is a strong Quality System so fundamental to achieving and maintaining operational excellence? What can we learn from other industries? What are the cost benefits of more effective and efficient manufacturing? In the opening session, senior leaders will discuss how the industry and consumers benefit when science-based risk management is used throughout the lifecycle to assure a robust state of control.
These sessions will address the tangible quality-business synergies reaped by "learning organisations" that proactively seek out sources of variability through daily vigilance and take advantage of contemporary technological solutions to improve product quality.
| Monday 14 November 2011 | ||
| 08:30 | 08:50 | Introduction to Quality System ICH Q10 Stefan Fuehring, European Commission |
| 08:50 | 09:20 | Industry Keynote Richard Bowles, Merck & Co. Inc. |
| 09:20 | 09:50 | The Cost of Non-Compliance Jeffrey Macher, Georgetown University |
| 09:50 | 10:15 | Benchmarking with Other Industries G. K. Raju, Gland Pharma Ltd. |
| 10:15 | 10:45 | Refreshment Break |
Plenary Session 2
Moderator:Anders Vinther, Genentech
| 10:45 | 11:15 | US Regulatory Perspectives Richard L. Friedman, Office of Manufacturing and Product Quality FDA |
| 11:15 | 11:45 | European Regulatory Perspectives David Cockburn, European Medicines Agency (EMA) |
| 11:45 | 12:30 | Panel Discussion Richard Bowles, Merck & Co. Inc.; Jeffrey Macher, Georgetown University; G. K. Raju, Gland Pharma Ltd.; Richard L. Friedman, FDA; David Cockburn, EMA; Stefan Fuehring, EC |
| 12:30 | 13:30 | Lunch and Networking Break |
Download the Registration Form for this Conference here!
(
145 KB)
Conference Highlights
| 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 8: |
Plenary Session 9: Plenary Session 10: Plenary Session 11: |
| Monday 14 November 2011 | ||
| Exhibition Networking Reception | ||