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Jul 24, 2014 10:00 AM - Jul 24, 2014 11:30 AM

Online

Pharmacovigilance and Global Harmonization Updates

Speakers

Richard F. Kingham

Richard F. Kingham

Partner, Covington & Burling, United States

Justina  Molzon, JD, MS

Justina Molzon, JD, MS

Consumer Services, Consumer Services, United States

Justina Ann Molzon, former Associate Director for International Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, 1999-2014. Molzon is an expert in regulatory harmonization and capacity building of international drug regulatory authorities. Career US Public Health Service officer serving for 30 years with a retired rank of Captain. Juris Doctor, Illinois Institute of Technology Chicago-Kent College of Law, Chicago, Illinois, Master of Science in Pharmacy, University of Rhode Island, Kingston — Pharmaceutics, Bachelor of Science, University of Rhode Island, Kingston, she graduated with honors and distinction and was selected for Rho Chi.

E. Stewart  Geary, MD

E. Stewart Geary, MD

Senior Vice President, Eisai Co., Ltd., Japan

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

Moira  Daniels

Moira Daniels

VP, Head Global Patient Safety Services, PACE, PAREXEL International, United Kingdom

Moira joined PAREXEL in November 2013 and is currently VP, Global Head of Patient Safety Services, PACE. Patient Safety Services provides pharmacovigilance on a global basis across all phases of the product life-cycle through monitoring, assessment and management of the long term safety of products. Moira is responsible for delivering excellence in Pharmacovigilance and Regulatory Compliance, through a cost-effective operational model. Prior role with AZ, Pfizer and Lilly

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