Conference Program
08:00
Registration
09:00
Conference Opening & Welcome
Andrea Rossi, Italy - Conference Chair
09:10-10:30
Session 1: The Environment of Clinical Trials in Europe
09:10-09:40
The Clinical Research in Europe
09:40-10:10
Clinical trials in EU: situation and regulation
10:10-10:30
Discussion/Q&A
10:30-11:00
Coffee Break, Networking & Visit the Exhibition
11:00-12:30
Session 2: The Expectations from Clinical Trials: A Changing Environment
11:00-11:25
Transparency in clinical trials
Marguerite O'Riordan
TranspariMED, UK
11:25-11:50
Patient’s expectations
11:50-12:15
Physician’s expectations
Ferdinando Fusco
University of Campania “Luigi Vanvitelli” – Naples, Italy
12:15-12:30
Discussion/Q&A
12:30-13:30
Lunch Break, Networking & Visit the Exhibition
13:30-14:00
Round Table and Poll on Communicating Clinical Trials (Morning Presenters)
14:00-15:00
Session 3: Thinking of Clinical Trials from the Outcomes
14:00-14:25
Lessons Learned from Site Investigational Audits to Ensure Compliance with GCP and Other Regulations
Antal Solyom
HungaroTrial CRO, Hungary
14:25-14:50
Closing a Clinical Trial
14:50-15:00
Discussion/Q&A
15:00-15:30
Coffee Break, Networking & Visit the Exhibition
15:30-17:00
Session 4: From Clinical Trial Outcomes to the Daily Application in Different Countries
15:30-15:55
The Statistical Analyses
15:55-16:20
The Clinical Analysis
16:20-16:30
Discussion/Q&A
16:30-17:00
Round table on communicating clinical trials and poll (Afternoon Presenters)
17:00
End of Day One
08:30
Registration
09:00-10:30
Session 5: Collecting and Managing the Clinical Trials Data in Europe
09:00-09:05
Welcome and recap of the previous day
Andrea Rossi
Freelance Consultant, Italy I Conference Chair
09:05-09:30
Reporting Adverse Events
09:30-09:55
Data safety and confidentiality
09:55-10:20
Processes management of the European clinical trials
10:20-10:30
Discussion/Q&A
10:30-11:00
Coffee Break, Networking & Visit the Exhibition
11:00-12:30
Session 6: Successful Clinical Trials in Europe
11:00-11:25
Health Economics in Clinical Trials
11:25-11:50
The Use of AI for Clinical Trials Publications
11:50-12:15
Designing a Clinical Trial
12:15-12:30
Discussion/Q&A
12:30-13:30
Lunch Break, Networking & Visit the Exhibition
13:30-14:00
Round table “What is a successful clinical trial” (Morning Panelists)
14:00-15:00
Session 7: Managing Real-World Trials in Europe
14:00-14:25
The Evolving Role of the CRO
14:25-14:50
Real World Evidence: News and Perspectives
14:50-15:00
Discussion/Q&A
15:00-15:30
Coffee Break, Networking & Visit the Exhibition
15:30-16:30
Session 8: A Good Start Ensuring Successful CTs in Europe
15:30-15:55
Medical device perspective on clinical trials (combination studies) and IVD performance studies
Nebojsa Serafimovic
AGES / Agency for Health and Food Safety, Austria
15:55-16:20
The Research Question
16:20-16:30
Discussion/Q&A
16:30-17:00
Round table “Starting with the right foot for a successful outcome” (afternoon panelists)
17:00
End of Conference
