A. Leander Fontaine, MD
Principal Consultant, Pharmiceutics LLC
Areas of Special Expertise:
- US and EU labeling (content, regulatory aspects, format)
- Global labeling, safety labeling harmonization
- Development labeling (incl. development core safety information)
- Global labeling life-cycle management, core labeling, labeling harmonization
- Regulatory/labeling issue management, directing labeling negotiations with regulatory authorities worldwide
- Design of global regulatory / labeling systems, organizations and technology
Brief Curriculum Vitae:
Degrees
- 1979: Medical degree (physician), Saarland University, Germany
- 1985: Doctoral degree (Dr. med.), University of Ulm, Germany
- 1988: Certification in anesthesiology, Germany
Clinical Experience
- 1980-1983 Internal medicine, German Army Hospital Ulm, Germany
- 1983-1988 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
- 2005-present: President and principal consultant, Pharmiceutics LLC, USA
Working Group & 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
- 2005: Institute of Medicine, ADE reporting workshop. Subject matter expert invited to propose improvements to US safety labeling.
Conferences, Seminars
Frequent faculty member and chairperson at pharmaceutical conferences and seminars, 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, emerging labeling trends.
Awards
June 2007: DIA Outstanding Service Award