2014 PDA Europe Joint Regulators-Industry QbD Workshop

Attendee Presentations

0 - Attendee List

PDA Europe

(?)
1 - Workshop Agenda

PDA Europe Programs & Events

(?)
10 - EU variations system

EU variations system

(?)
11 - FDA reflections

Christine Moore, FDA

(?)
12 - PMDA perspective

Yoshihiro Matsuda, PMDA

(?)
13 - Innovation in Medicines and Manufacturing

David Tainsh (GSK), Keith Pugh (MHRA)

(?)
14 - Closing Remarks

David Tainsh (GSK), Keith Pugh (MHRA)

(?)
2 - Introduction Jean-Louis Robert - QWP Chair

Jean-Louis Robert (Chair CHMP-CVMP QWP)

(?)
3 - Introduction

Georges France (Novartis)

(?)
4 - Case Study 1 - Risk Assessment and Lifecycle Management Learning

Olvia Lake (EU Quality Assessor), Frank Montgomery AstraZeneca)

(?)
5 - Case Study 2 - Development and Verification of Design Space

Tone Agasøster (Norwegian Medicines Agency), Graham Cook (Pfizer)

(?)
6 - Case Study 3 - Applying QbD for a legacy product

Lorenz Liesum (Novartis), Lama Sargi (ANSM)

(?)
7 - Case Study 4 - Challenges in the Implementation of Model Based and PAT based RTRT

Gorm Herlev Jørgensen (Danish Health and Medicines Authority), Theodora Kourti (GSK)

(?)
8 - Case Study 5 - Control Strategy

Øyvind Holte (Norwegian Medicines Agency), Ron Ogilvie (Pfizer)

(?)
9 - Case Study 6 - Novo Nordisk Experience in the Application of QbD

Steffen Gross (Paul-Ehrlich-Institute), Preben Østfeldt (Novo Nordisk)

(?)