Profile of Barbara Lachmann

Since July 2013, Barbara Lachmann works as an independent Labeling Consultant.

Skills and Strengths
  • 5 years of clinical experience in internal medicine

  • More than 25 years of experience in the pharmaceutical industry in regulatory product information in a global and EU labeling position, including negotiations with regulatory authorities

  • Excellent understanding of labeling requirements in major regions and countries (including EU, US, Japan, Canada, Australia, Switzerland) as well as CIOMS recommendations for core labeling and generally accepted global labeling standards

  • IIn-depth knowledge of the labeling process including GVP requirements and related medical, safety and regulatory aspects in a global organisation, in particular the labeling development process and global issues in implementing core labeling

Industry experience
  • 2005 – 2013: Senior Advisor Global Regulatory Product Information (renamed Center of Excellence Product Information in 2012), Merck KGaA, Germany

  • 2002 – 2005: Head of Global Labeling in Global Drug Regulatory Affairs & Clinical Quality Assurance, Merck KGaA, Germany

  • 1990 – 2002: Various positions in Global Labeling with increasing responsibility (Project Manager, Senior Advisor and Head of Global Labeling department Frankfurt) at Hoechst AG, Germany, and its successor companies Hoechst Marion Roussel and Aventis

  • 1985 – 1990: Project Manager for Medical Affairs, Department of Health Policy, Hoechst AG, Germany

Clinical Experience
  • 1980 – 1985: Internal medicine, Intensive care, Emergency medicine, Radiology at Main-Taunus-Kliniken, Hofheim, Germany

Professional organizations
  • Drug Information Association (DIA) and Labeling Working group of the DIA Community Regulatory Affairs

  • The Organisation for Professionals in Regulatory Affairs (TOPRA)

  • German Society of Regulatory Affairs (Deutsche Gesellschaft für Regulatory Affairs – DGRA)

Conferences and Teaching
  • Frequent faculty member and chairperson at pharmaceutical conferences covering global and EU labeling topics, including labeling requirements in major regions, core labeling, safety labeling decision-making and labeling harmonisation including GVP requirements as well as EU labeling rules and emerging labeling trends

  • From 2008 to 2011, lecturer in the curriculum for “Master of Drug Regulatory Affairs” at the University of Bonn, Germany