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Mandarin Oriental Washington D.C.

Jan 26, 2016 7:00 AM - Jan 26, 2016 1:30 PM

1330 Maryland Avenue, SW, Washington, DC 20024

Tutorial #4 – Principles and Practice of Pharmacovigilance Governance

Instructors

Kelly  Traverso

Kelly Traverso

Vice President - R&D Business Development and Sales, Deloitte, United States

Kelly has more than 20 years’ experience in the areas of Quality, Pharmacovigilance, R&D, and Regulatory Affairs with large, global Biotech and Pharmaceutical companies. She is a Subject Matter Expert on the topics of process assessment and gap analyses, governance model design, business process review and redesign, sourcing strategy, training and Standard Operating Management (SOP) development and quality management system design. In addition to being a thought leader, Kelly is also highly skilled at leveraging resources to maximize spend and amplify impact.

Deirdre  McCarthy, MSc

Deirdre McCarthy, MSc

Senior Director, Pharmacovigilance and Safety Operations, Allovir, United States

Deirdre McCarthy is a Senior Director, Pharmacovigilance and Safety Operations at AlloVir, an ElevateBio company, and is based in Boston, USA. She previously held leadership roles in Quintiles/IQVIA in EU, US and Argentina. She is also a member of the Executive Committee of the International Society of Pharmacovigilance. She holds a Degree in Biochemistry from Trinity College Dublin and a Masters in Pharmacovigilance from University of Hertfordshire, UK. Prior to joining IQVIA, Deirdre held positions in pharmacovigilance in the Irish Medicines Board as well as in industry.

JP  Clement, MD

JP Clement, MD

Founder and Principal, JPCC Associates, United States

Dr. Clement is an Executive PV Consultant for the pharmaceutical industry. He has worked in Drug Safety and Pharmacovigilance in multiple capacities, mostly with global responsibilities. In his last role, he was leading the PV activities for Cubist (now part of Merck) as Vice-President, Global Pharmacovigilance & Medical Risk Management. In his extensive experience, he has held senior positions for Drug Safety and Pharmacovigilance at Onyx/Amgen, Janssen, Sanofi, Lipha-Merck Kga, Abbott and Janssen France.

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