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Regulatory Speakers

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.