Agenda
8:30 AM — 9:30 AM
9:30 AM — 9:35 AM
Opening Remarks9:35 AM — 11:00 AM
Session 1: Overview of the Clinical Trials Regulation Environment11:00 AM — 11:30 AM
11:30 AM — 12:30 PM
Session 2: How the Clinical Trial Regulation has Evolved12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3: Status of the EU Portal and Database3:00 PM — 3:30 PM
3:30 PM — 5:30 PM
Session 4: Implementation and Readiness5:30 PM — 6:30 PM
9:00 AM — 10:30 AM
Session 5: Challenges of the Implementation10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 6: CTR – Safety Related Information Exchange12:30 PM — 2:00 PM
3:30 PM — 4:00 PM
4:00 PM — 5:30 PM
Session 8: Legal Considerations for Clinical Data Publication5:30 PM — 6:30 PM
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