Rob van Manen, CEO and Founder

Pharmacovigilance Expert with experience in the US, Europe, Asia, Latin America and the Middle East

• Successfully selected, implemented and configured pharmacovigilance and clinical data management systems in many companies globally
• Provided worldwide pharmacovigilance consulting and education to pharmaceutical, biotechnology and medical device companies as well as contract research organizations and academic institutions

Quantitative Safety Signal Detection Specialist with experience in both industry and regulatory environments

• Provided guidance through both education and consulting to many pharmaceutical and biotechnology companies as well as regulatory agencies (FDA, MHRA, SFDA, KIDS) on the selection, implementation and configuration of quantitative safety signal detection methodologies based on postmarketing, clinical and longitudinal observational databases
• While based in the US, worked with FDA CDRH on the introduction of safety signal detection methods for medical devices and with FDA CFSAN on signal detection for food products
• Performed a wide range of successful ad-hoc signal detection projects for a variety of different companies as well as regulators

Global Opinion Leader in the field of pharmacovigilance and safety signal detection

• Regularly delivering presentations and workshops at industry conferences and events as well as lecturing at academic institutions in the US, Europe and Asia-Pacific
• Member or past member of key industry advisory organizations such as the CDISC Advisory Board and the International Society for Pharmacoepidemiology (ISPE) Industry Council
• Frequently publishes in peer-reviewed scientific as well as other professional journals and textbooks
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