戻る Agenda
End-to-End Pharmacovigilance Quality and Compliance
Session Chair(s)
Monika Pietrek, MD, PHD, MSC
Managing Director and Senior Consultant
Pietrek Associates GmbH, Germany
A cohesive PV system requires well-defined processes which include sufficient quality measures to support patient safety and regulatory compliance. The core PV activities involve several functions of a marketing authorisation holder’s (MAH) affiliates, business partners and service providers beyond the PV department itself. Therefore, the process design has to adequately capture these interfaces to enable appropriate oversight. In addition, the changes prompted by the Clinical Trial Regulation (CTR) will be addressed.
Speaker(s)
Safety Reporting under the Clinical Trial Regulation
Esteban Herrero-Martinez, PHD
Novartis Pharmaceuticals UK Limited, United Kingdom
Director Regulatory Policy and Intelligence
Oversight of Pharmacovigilance Compliance - The Role of Metrics and KPIs
Monika Pietrek, MD, PHD, MSC
Pietrek Associates GmbH, Germany
Managing Director and Senior Consultant
Inspectorate Feedback Regarding the Use of Reference Safety Information
Joanna Harper
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Inspector, GPvP, Inspectorate, Enforcement and Standards