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

ispe.org Connecting Pharmaceutical Knowledge

Thank You !