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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)
Esteban Herrero-Martinez, PhD
Director Regulatory Policy and Intelligence, Novartis Pharmaceuticals UK Limited, United Kingdom
Safety Reporting under the Clinical Trial Regulation
Monika Pietrek, MD, PhD, MSc
Managing Director and Senior Consultant, Pietrek Associates GmbH, Germany
Oversight of Pharmacovigilance Compliance - The Role of Metrics and KPIs
Joanna Harper
Expert Inspector, GPvP, Inspectorate, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Inspectorate Feedback Regarding the Use of Reference Safety Information
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