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Bethesda North Marriott Hotel and Conference Center

Apr 23, 2018 1:00 PM - Apr 23, 2018 5:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Course 2: Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management

Instructors

A. Leander  Fontaine, MD

A. Leander Fontaine, MD

President, Pharmiceutics, LLC., United States

President of Pharmiceutics LLC, a consulting firm based in Pennsylvania, USA. Pharmiceutics offers consulting, training and services for labeling. Before founding Pharmiceutics in 2005, Leander served as Vice President and Head of Global Labeling Division and Vice President, International Labeling Liaison, for Wyeth, USA. He started his career in global labeling in 1991 and has served as head of global labeling functions for Hoechst (Germany) and Hoechst Marion Roussel (USA). He has also held positions in clinical development and clinical pharmacology with Behringwerke (Germany). Before joining the pharmaceutical industry, he worked as a physician in internal medicine as well as in anesthesiology, intensive care and emergency medicine.

Barbara  Lachmann, MD

Barbara Lachmann, MD

Sole Proprietor, Barbara Lachmann Labeling Consulting, Germany

Barbara Lachmann MD is an independent labeling consultant, providing expert services and training in the field of labeling and regulatory affairs. She started her career in global labeling in 1990 with Hoechst, and has served as Group Head of global labeling functions for Hoechst, Hoechst Marion Roussel and Aventis, and as Head of Global Labeling and Senior Labeling Expert for Merck KGaA. She has also held a position in Pharma Health Politics at Hoechst.

Rie  Matsui, RPh

Rie Matsui, RPh

Senior Director, Regional Labeling Head for APAC, International Labeling, Pfizer R&D Japan G.K., Japan

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.

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