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Tuesday, June 28 • 10:30am - 11:45am
#226: The Global Conundrum: Herding Cats - Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi-Country Pharmacovigilance Activities

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Limited Capacity seats available

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

As pharmaceutical companies seek ways to centralize and better coordinate with affiliates, some pharmacovigilance activities, such as interfacing with health care professional and patients, must be managed locally. Dealing with these activities across multiple countries can be extremely complicated, and companies must find ways to simplify and improve their processes. In this forum, we will explore the Pharmacovigilance (PV) Affiliate Network from both corporate and local perspectives and review case studies of issues faced by companies of all sizes, from start-up to multi-national. In addition, we will present an approach to clarifying the current affiliate situation using an affiliate’s survey tool as well as available in-house data sources. We will also demonstrate a risk-assessment approach that can be applied to generate a clear view of systemic risk (exposure across all or many affiliates) and unique risks (exposure specific to one particular or a few local affiliates). Finally we will highlight methods to streamline PV affiliate processes and the benefits this approach provides to the enterprise. A panel discussion following the presentations offers attendees the opportunity to ask questions and to discuss ideas about global PV affiliate management with the speakers.

Learning Objectives

Assess similarities and differences between regions including recognizing peculiarities in present day international pharmacovigilance scenarios; Describe a methodology for identifying and assessing systemic and unique risks across the affiliate network; Identify the potential benefits from implementation of an affiliate risk-reduction and simplification exercise on portfolio management; Evaluate the company needs and formulate high-impact solutions to minimize risk and improve processes.


Hershell William Thompson


Managing a PV Affiliates Network: The Challenges and Considerations in Maintaining Oversight and In-Country Connections
Lesia Tontisakis, BSN

A Global Conundrum: Seeking Simplicity in Multi-Country Pharmacovigilance Activities
Marco Anelli

avatar for Hershell Thompson

Hershell Thompson

Managing Consultant, Navitas Life Sciences, Inc.
Hershell is a Managing Consultant with Navitas Life Sciences and has with over 25 years of medicines development and change management experience. He has extensive operational experience in phase I-IV clinical trials, health outcomes, pharmacovigilance and medical devices. He was... Read More →

avatar for Marco Anelli

Marco Anelli

Head of Pharmacovigilance and Medical Affairs Advisory Services, Productlife Group
Marco Anelli is Head of Pharmacovigilance and Medical Affairs Advisory Services at ProductLife Group . In the past 25 years he has worked in Phase I-IV and PV. In addition, Marco is also QPPV and has prepared and signed over 200 non-clinical and clinical overviews and summaries... Read More →
avatar for Lesia Tontisakis

Lesia Tontisakis

Director, Pharmacovigilance, Global Patient Safety and Epidemiology, Allergan
Lesia Tontisakis joined Allergan in 2011 leading key Safety Operations functions ensuring global quality & compliance targets are met. Key responsibilities include QMS oversight, compliance, Inspection Readiness, PVA Management, Training and Vendor Oversight (ICSR management and Affiliate... Read More →

Tuesday June 28, 2016 10:30am - 11:45am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Forum