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A Leander Fontaine is President of Pharmiceutics LLC, a Pennsylvania-based company which offers labeling and regulatory consulting, expert services and training.
Before founding Pharmiceutics in March 2005, he was Vice President and Head of Global Labeling Division and Vice President, International Labeling Liaison, Wyeth, USA. He started his career in global labeling in 1991 and has served as head of global labeling functions for Hoechst Marion Roussel (USA) and Hoechst (Germany). He has also held positions in clinical development with Behringwerke (Germany).
Before joining the pharmaceutical industry, he worked in internal medicine (German Army Hospital Ulm, Germany) as well as in anesthesiology, intensive care and emergency medicine (University Hospital Ulm, Germany). He received his medical degree in 1979 from Saarland University, Germany, and received his doctoral degree in 1985 from University of Ulm, Germany.
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| Workshop, Tuesday, 4 July 2006, Oxford University |
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Safety Labeling Decision-Making and Regulatory Implementation
Led by A Leander Fontaine, President, Pharmiceutics
Based on the outcome of the case study presented by Saad Shakir on day one, participants will form “labeling committees” and decide which information to provide in product labeling (prescribing information), design a global regulatory implementation strategy and a global publication strategy. The case study will also include negotiation scenarios with regulatory authorities. It will be accompanied by a series of lectures by Leander Fontaine, who will discuss the principles of safety labeling decision making and a provide a comparative review of safety labeling regulations, guidelines and regulatory expectations.
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