The focus of pharmacovigilance is rapidly evolving from the processing and submission of single case and periodic aggregate reports concerning marketed products towards integrated proactive programs for safety signal detection, signal evaluation, risk assessment, and risk management 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. Pharmacovigilance & Risk Management, Inc. (PvRM) was established by Dr. Sidney Kahn to provide expert advice on all aspects of pharmacovigilance to pharmaceutical manufacturers, pharmaceutical industry support organizations, and health authorities worldwide. |