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| A Leander Fontaine, President, Pharmiceutics |
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Degrees:
1979: Medical degree, Saarland University, Germany
1985: Finalization of dissertation and doctoral degree, University of Ulm, Germany
1988: Certification in anesthesiology, Germany
Clinical experience:
1980-1983 Clinical and scientific work in internal medicine, German Army Hospital Ulm, Germany
1983-1988 Clinical and scientific work in anesthesiology, intensive care and emergency medicine, University Hospital Ulm, Germany
Pharmaceutical Industry experience:
1988-1990: Clinical Project Manager Behringwerke, Germany
1990-1991: Head Clinical Pharmacology and Blood Donation Units, Behringwerke, Germany
1991-1993: Head of International Master Data Sheet Group, Hoechst Pharma, Germany
1993-1996: Head of Corporate Product Information, Hoechst Pharma, Germany
1996-1999: Head of Global Regulatory Medical Information, Hoechst Marion Roussel, USA
1999-2003: Vice President and Head of Global Labeling Division, Wyeth, USA
2003-2005: Vice President, International Labeling Liaison, Wyeth, USA
Consulting:
2005-present: President, Pharmiceutics LLC, USA
Working groups and special projects (selection):
1998-2002: Working group on international labeling policy, International Pharmaceutical Federation (FIP)
2003-present: Founding member of the Labeling, Packaging and Promotion working group of the DIA Regulatory Affairs SIAC
2004-present: Member of the PhRMA/HL7 Task Group on Structured Product Labeling
2005: Member of MSSO Blue Ribbon Panel on the use of MedDRA in labeling
Conferences, Seminars:
Frequent faculty member and chairperson at pharmaceutical conferences/seminars in Europe and in the USA, covering the full range of global, US and EU medical labeling topics, including core labeling and labeling harmonization, US and EU labeling, developmental labeling, safety labeling decision making, labeling and risk management.
Publications:
Most recent publication: A. L. Fontaine. Current requirements and Emerging Trends for Labelling as a Tool for Communicating Pharmacovigilance Findings. Drug Safety; 27 (8): 579-589, 2004
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