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Tuesday, June 20 • 10:30am - 11:45am
#221: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will provide an overview of current focus areas, trends, and hot topics of pharmacovigilance (PV) inspectors. Presenters will discuss approaches for evaluating your own organizations's PV system and proactively address opportunities for advancement.

Join Clinical Safety & Pharmacovigilance Community for a follow up Round Tables discussion at 2:00pm in the Community Corner.

Learning Objectives

Describe current focus areas, trends, and hot topics of PV inspectors.


MHRA Perspective
Rory Littlebury

Industry Perspective
Carolyn Winter, RN


Michael Bean

Senior Director, Regulatory Compliance R&D, Janssen Pharmaceutical Companies of Johnson & Johnson
Currently Senior Director at Janssen pharma working in Complince with previous experince as an Inspector at the MHRA and compliance funtions in various Pharma/CRO organsaitions

Rory Littlebury

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
Rory has ten years experience working at the MHRA, including working within Licensing and Pharmacovigilance Divisions prior to taking on a Pharmacovigilance Inspector role. Rory’s experience includes engagement as a regulator with a variety of stakeholders, from multi-national... Read More →

Carolyn Winter

Director, PV & RA Quality Assurance, AbbVie, Inc.
Carolyn has been leading the global Pharmacovigilance (PV) Quality Assurance function at AbbVie since August 2010. In 2016, the Regulatory Affairs audit team also joined her group. Previously, Carolyn worked as Deputy Director for Vigilex Ltd, a PV consultancy, having previously... Read More →

Tuesday June 20, 2017 10:30am - 11:45am
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
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  • Credit Type CME, IACET, RN
  • Tags Session