Phil Tregunno, MHRA
Wednesday, Session 4, 15.30: An MHRA Perspective on Automation, Machine Learning & Artificial Intelligence
An overview of the MHRA’s perspective on implementation of novel Pharmcovigilance systems.
Diane Hallé, ANSM
Wednesday, Session 4, 16:30: Inspection of PV IT Systems
- How are PV IT systems inspected?
- What documentation is required to be available for inspection?
- Examples of deficiencies in PV IT systems identified during PV inspections.
Fergus Sweeney, EMA
Thursday Session 1, 09.00: GCP Renovation – ICH E8 and ICH E6
Thomas Lucotte, ANSM
Thursday Session 1, 09.00: OECD Document on Test Item Management: What is New?
- This presentation aims to underline the clarifications of the GLP principles brought by Document No. 19 and the expectations of the monitoring authorities.
Torsten Stemmler, BfArM
Thursday, Session 2, 11:30: Regulatory Perspective on Direct Data Capture by Trial Subjects and Their Social Media Use
- Data Safety
- Date Integrity
- Data Validity
- Data Privacy.
Jaber Jaber, Jordan Food & Drug Administration
Thursday, Session 4, 15:55: Arab Pharmacovigilance Guidelines Overview
- An overview about Arab Pharmacovigilance requirements.