Global Risk Managemen from Syneos One®
Optimizing the safe and effective use of medicinal products
Many regulators outside of the United States require Risk Management Plans (RMP) with additional Risk Minimization Measures (aRMMs) to apply the necessary controls that positively impact the benefit-risk ratio and enable a pharmaceutical product to be approved.
Establishing an effective RMP strategy and implementing appropriate aRMMs requires a global understanding of the pharmaceutical delivery system, deep knowledge about the global regulatory requirements, and tight integration with the product’s overall pharmacovigilance system.
A holistic and comprehensive approach
Syneos One has one of the largest pharmacovigilance teams in the industry, and we deliver our Global Risk Management and aRMM solutions alongside our case processing, signal detection, safety surveillance, and safety submissions to drive a holistic comprehensive approach to post-marketing safety activities.
Global Risk Management & REMS Lead
Over a decade of REMS experience, and has led the strategy, development, implementation and operations of over half the currently approved REMS on the market both as a manufacturer and a REMS administrator.
MSJ, Global Risk Management and REMS Strategy
20+ years experience designing, implementing, and delivering global risk management programs. Participated in FDA REMS advisory panels, presented at international risk management conferences, and co-authored 16 scientific manuscripts and posters on pharmaceutical risk management activities.
Global Risk Management is an offering from Syneos One®
Syneos One is a dedicated interdisciplinary team providing seamless delivery of asset development solutions, bringing in the right resources and expertise spanning all clinical development, medical affairs, and commercialization services needed to bring products to market, address unmet patient needs and maximize value for stakeholders.