Monday, 24 June 2019
10:00
Welcome & Introduction
10:30
Opening of the Meeting & Introduction of the IG QS EU
Lothar Hartmann, Phact
11:00
KEY NOTE PRESENTATION
"Big Data"
What does the future look like?
Toni Manzano, Bigfinite
SUB-GROUP'S FLOOR
11:45
Comparability of ICH Q10 with ISO 9000
Heribert Dahmen, Merck
12:15
CPV
Agnès Hardy-Boyer, Sanofi-Pasteur
12:45
Lunch Break
SUB-GROUP'S FLOOR (contin'd)
13:30
Process Owner
Sofia van Berlekom, AstraZeneca
14:00
Management Review
Pia Sandau, Novo Nordisk
WORKSHOPS SESSION
14:30
Group 1:
Does the PQS/QMS fit into the true lifecycle (ICH Q8 – 14)?
Lothar Hartmann, Phact
Group 2:
What does a QMS look like in a digitalised world?
Jeremie Arrault, Novartis
Michele Simone, Bracco
15:30
Coffee Break
16:00
PLENARY DISCUSSION
Presentation and Conclusions of the Discussions from the Workshops
Lothar Hartmann, PhACT
17:00
End of IG Meeting