Course 2: Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management
A. Leander Fontaine, MD
- 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 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
- Director, Regional Labeling Head for Asia, International Labeling Group
- Pfizer Japan Inc., Japan
She is currently Director, Regional Labeling Head for Asia, International Labeling Group, Worldwide Safety & Regulatory, Pfizer Japan. She is the founder of Asia Labeling Hub which was established in July 2012. The Asia Labeling Hub has created local label updates for more than 20 countries. She was a Senior Manager for Post-marketing Regulatory Department at Pfizer Japan. Also, she has experiences on labeling, Pharmacovigillance and risk management plans for more than 20 years. She has been a member of the Advisory Council of DIA Japan since 2016. She won the DIA Japan regional award in 2015 andhas been involved in a number of conferences in Japan, China, Singapore and the U.S., both as a session chair and speaker.