Pharmacovigilance is rapidly evolving during the past few decades. Originally, it concentrated on the processing and submission of single case expedited reports, which still is one major activity in this area. In the 1990, the International Conference on Harmonization (www.ich.org) established global guidelines covering all areas of drug development. For pharmacovigilance, the guidelines include the topics:

Today, pharmacovigilance covers integrated proactive programs for

Pharmacovigilance applies these tools throughout all phases of development and clinical use of pharmaceutical products. The challenges of a complex and constantly changing environment require pharmacovigilance personnel with a high degree of competence, training, knowledge, and experience to ensure company compliance with evolving regulatory standards and good clinical and business practices. Pharma Safety Consulting, LLC, was established by Joachim Veith, MD, MS to provide expert advice on all aspects of pharmacovigilance to pharmaceutical manufacturers and pharmaceutical industry support organizations worldwide with special focus on companies on the US West coast.