DATE:
Nov 07
Basel, CH

A 1-day educational course:

Drug/Device
Combination Products

A 1-day educational course on the successful development and approval of Drug/Device Combination Products.

Agenda

MORNING:
Time Topic Speaker
9:00 Welcome, Organisation GSIA
9:05 Introduction/overview of drug device product combination products, definitions Tom Vanrenterghem, Janssen
9:45 Regulatory requirements for a medical devices: EU and FDA Sandra Soniec, meditec Consulting GmbH
10:15 Coffee Break
10:45 Quality management for combination products Joachim Baumann, QMS-Consulting
11:15 Risk Management Fabio Cirillo, Avanti Europe
11:30 Design Control Salma Michor, Michor Consulting
12:15 Panel discussion Chair (Fabio Cirillo)
12:45 Lunch
AFTERNOON:
Time Topic Speaker
13:45 Human factor/usability studies in the context of combination product development Andreas Baier, Ergonomics Factory GmbH
14:15 Case study combinations product 1: risk-based approach Fabio Cirillo, Avanti Europe
14:45 Coffee break
15.15 Case study combination product 2: design controls Mike Wallenstein, Novartis
15:45 Case study: human factor study Andreas Baier, Ergonomics Factory GmbH
16.15 Panel discussion Chair (Fabio Cirillo)
17.00 End of the day and departure
Further information
+43 (0)1 890 57 14 | office@michor-consulting.eu
A cooperation with: