Analytical Procedure Lifecycle Management / Revisions to ICH Q2 & the proposed Q14 This conference is part of PharmaLab 2019

Programme

New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)
Dr Joachim Ermer, Sanofi-Aventis Deutschland Head of QC Lifecycle Management Frankfurt Chemistry

Introduction to ECA AQCG
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Overview of ICH revisions & APLM Guideline; prerequisites and approaches
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Introduction to ATP & TMU
Phil Borman, GSK

Data integrity over the Analytical Procedure Lifecycle
Bob McDowall, R.D. McDowall Limited

Stage 1: Procedure Design & Development
Margarita Sabater, Dako Denmark, an Agilent Technologies Company

Stage 1 in Practice
Phil Borman, GSK

Analytical Control Strategy Workshop
Dr Gerd Jilge, Boehringer Ingelheim
Margarita Sabater, Dako Denmark, an Agilent Technologies Company

Stage 2: Procedure Performance Qualification: Problems and issues?
Dr Gerd Jilge, Boehringer Ingelheim

Approaches to the transfer of Analytical Procedures
Ulla Bondegaard, Novo Nordisk

Stage 3: Procedure Performance Verification
Silviya Dimitrova, Teva

Experiences in the ongoing verification of Analytical Procedures
Ulla Bondegaard, Novo Nordisk

"What happens with Legacy Products?" Workshop
Margarita Sabater, Dako Denmark, an Agilent Technologies Company
Dr Christopher Burgess, Burgess Analytical Consultancy