Agenda
7:30 AM — 8:30 AM
8:30 AM — 9:00 AM
9:00 AM — 10:10 AM
Session 1: GCP REGULATORY FRAMEWORK IN EUROPE AND IN THE ICH10:10 AM — 10:40 AM
10:40 AM — 12:20 PM
Session 1 continued: GCP REGULATORY FRAMEWORK IN EUROPE AND IN THE ICH12:20 PM — 1:20 PM
1:20 PM — 2:45 PM
Session 2: AUDIT METHODOLOGY AND REPORTING2:45 PM — 3:15 PM
3:15 PM — 5:15 PM
Session 2 continued: AUDIT METHODOLOGY AND REPORTING5:15 PM — 5:30 PM
5:30 PM — 6:30 PM
8:30 AM — 10:00 AM
Session 3: THE TRIAL AUDIT IN PRACTICE – INVESTIGATOR SITE10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 3 continued: THE TRIAL AUDIT IN PRACTICE – INVESTIGATOR SITE12:00 PM — 1:00 PM
1:00 PM — 2:50 PM
Session 4: COMPUTERS SYSTEMS AND DATA INTEGRITY2:50 PM — 3:20 PM
3:20 PM — 5:15 PM
Session 5: SYSTEMS AUDITS5:15 PM — 5:30 PM
8:30 AM — 10:00 AM
Session 6: VENDOR AUDITS10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 6 continued: VENDOR AUDITS12:00 PM — 12:15 PM
12:15 PM — 1:15 PM
1:15 PM — 3:00 PM
Session 7: INSPECTIONS BY EUROPEAN AND THIRD COUNTRY AUTHORITIES3:00 PM — 3:30 PM
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