COMPLIANCE CHALLENGES E-CLINICAL COMPUTERIZED SYSTEMS … and... · 2018-08-08 · COMPLIANCE...
Transcript of COMPLIANCE CHALLENGES E-CLINICAL COMPUTERIZED SYSTEMS … and... · 2018-08-08 · COMPLIANCE...
COMPLIANCE CHALLENGES
E-CLINICAL
COMPUTERIZED SYSTEMS & DATA
GAMP COP Benelux October 10, 2017 Host/Sponsor : QbD, Wilrijk
ispe.org Connecting Pharmaceutical Knowledge
ispe.org Connecting Pharmaceutical Knowledge
ispe.org Connecting Pharmaceutical Knowledge
ispe.org Connecting Pharmaceutical Knowledge
Compliance Challenges in eClinical Computerized
Systems & Data
ispe.org Connecting Pharmaceutical Knowledge
ispe.org Connecting Pharmaceutical Knowledge
14:00 – 14:10 Welcome & Introduction (GAMP COP Benelux)
14:10 – 14:20 Welcome (Bart Van Acker, QbD)
14:20 – 15:00 Challenges in validation & implementation of a SaaS application
(Filip Heitbrink, QbD Software)
15:00 – 15:40 Maintaining DI during Clinical Studies – The new GAMP GPG
(Oliver Herrmann, Q-Finity & Maximilian Stroebe, GSK Vaccines)
15:40– 16:10 Coffee/Tea break / Networking
16:10 – 16:50 Data Privacy - The changing face of Research under the GDPR
(Mark Hitchinson, CTG Belgium)
16:50 – 17:30 Good Data Governance – Data Integrity challenges
(Hand de Raad, OpenNovations)
17:30 – 18:30 Round Table discussion (moderated by GAMP COP Benelux)
18:30 – 19:30 Buffet and drinks, sponsored by QbD
Agenda
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Thank You !