Conference Agenda

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Conference Agenda

Wednesday 27 June 2012

13.00 13.15 Session Begins  

Keynote Presentations

13.15

13.55

Demystifying Quality by Design from an EU Regulator's Perspective

Jean-Louis Robert - CHMP/CVMP Quality Working Party

13.55

14.35

US Regulatory Perspective on the Implementation of QbD for Generic Drugs

Keith Webber - FDA

14.35

15.15

Implementation of ICH Q9 and Q10 in the EU

Jacques Morenas - ANSM (formerly Afssaps) 

15.15 15.45 Networking Break  

15.45

16.25

The Quality by Design Paradigm and the Generics Industry

Pito Roslansky - Sandoz Int. GmbH.

16.25 16.55

Case Study One: QbD in Generic Drug Development

François A. Menard - Watson

16.55 17.25

Case Study Two: QbD Applied to API Spray Drying

José Ascensão - Hovione

17.25 17.55

Case Study Three: QbD Applied to API Chemical Process Development

Jan Ramza - Polpharma

17.55 18.10 Introduction to Breakout Groups
18.10   Session Adjourns
18.10 20.10 Exhibition Networking Reception

Thursday 28 June 2012

9.00 10.30
  • Workshop A: Why Consider QbD?

  • Workshop B: How do you Effectively Develop Products and Processes Using QbD?

  • Workshop C: What are the Regulatory Expectations Associated with a QbD Submission and How to Integrate them into Real-Life?

10.30 11.00 Networking Break  
11.00 12.00

Repeat of Workshops A, B and C for a Second Attendance

12.00 13.00 Lunch  
13.00 13.20

Feedback from Workshop A

 
13.20 13.40

Feedback from Workshop B

 
13.40 14.00

Feedback from Workshop C

 
14.00 15.00

Panel Discussion
Impediments and Incentives - Using the Workshop Feedback to Identify What are the Next Steps

15.00   Close of Workshops