Learn more and discuss with peers about opportunities, pitfalls and concerns regarding ‘agile validation’ approach in your GxP projects.
We bring presentations, case-studies and organize an interactive workshop.
Event is open for ISPE members (free of charge) and non-ISPE members.
Registration required, limited seats.
Location: Deloitte, Gateway building Luchthaven Brussel Nationaal 1 J, 1930 Zaventem, Belgium
Deloitte Gateway Building is located on Brussels Airport area (Luchthaven Brussel Nationaal 1 J | 1930 Zaventem).
|Event date||08-Oct-2019 13:30|
|Event End Date||08-Oct-2019 19:30|
|Registration Start Date||26-Jun-2019|
|Cut off date||30-Sep-2019 23:00|
The train allows you to conveniently travel to Brussels Airport Zaventem from major cities in Belgium and the Netherlands.
Brussels Airport - Zaventem Station is located on Level -1 of the passenger terminal, go to departures hall (Level 3), exit the departures hall, walk to your left to find the main entrance of the Deloitte office.
The Gateway building is located on the airport premises and can easily be reached by car. From the Brussels ring road follow the signs to Brussels Airport. Park your car in P2 or P3 (you can enter P2 or P3 without reservation), opposite the departure hall. Walk to the departure hall. Before entering the departure hall, you find the main entrance of the Deloitte offices on the left side. The Deloitte visitor parking is not available.
Welcome & Introduction
GAMP CoP Benelux
Best practices and challenges with the mobile application lifecycle – an use case for agile development
Todays life sciences organisations are faced with rapidly changing business requirements and challenging regulatory requirements. How could agile development help in regulated environments to support qualitative system development? Deloitte will present the results from a study conducted with lifesciences and technology companies using agile development. (Michel De Ridder, Partner Lifesciences Regulatory Compliance Deloitte) (Brian Monnissen, Consultant Deloitte)
Inhouse built `Templater Tool` developed and validated in an agile way
Anja Cerstiaens / Dries Cardoen – Nelson Labs Nelson Labs Leuven introduced a Dynamic Templating tool capable of automated reporting of analytical results with high performance. This tool was realized using a SCRUM Agile development strategy supported by a complete agile validation track in accordance with the current industry standards.”
UCB IT’s journey in Agile Transformation
(Ronny Schrijvers, UCB – Head of IT Agile Transformation)
(via break-out sessions) about validation approach (V-model, agile, ...) in GxP projects
Wrap-up & closing
GAMP CoP Benelux
sponsored by Deloitte