Safety and Risk Management
SAFETY & RISK MANAGEMENT SAFETY & RISK MANAGEMENT Minimizing patient risk is crucial as we work with sponsors to bring new products to the marketplace. Now more than ever, regulatory authorities emphasize the importance of a comprehensive safety infrastructure. The development of risk minimization strategies suitable for the whole life cycle of the project is imperative. That’s why PRA Health Sciences provides a comprehensive range of pharmacovigilance solutions for the entire product life cycle. We deliver flexible and customized services with the ultimate goal of minimizing risk and protecting patient safety. We work in a cross-functional fashion with other solution areas, such as Post Marketing and Therapeutic Expertise, to better assist clients with the effective management of their drug safety information. EXPERIENCE EXPERTISE N o. OF SAFETY & RISK MANAGEMENT PERSONNEL 200+ 6 60+ For 20+ years, PRA has provided comprehensive pharmacovigilance services across all phases and key therapeutic areas. Clients who choose PRA acquire not only additional safety personnel, but also a dedicated, nimble team fully concerned with their needs and patient safety, while providing the proven knowledge and therapeutic experience required to ensure quality data. PHASE 1 PHASE 3 PHASE 4 occurs once occurs at nonspecified intervals PV/Risk Management Plan SAE/ADR/MDR Management Medical Monitoring N o. OF DRUG SAFETY CENTERS N o . OF COUNTRIES IN OUR CENTRAL REPOSITORY OF REGULATORY REPORTING REQUIREMENTS PHASE 2 Definition of Safety Profile/ Benefit-Risk Assessment Development Safety Update Report Data Pooling/Data Monitoring Board Pooled Analysis Integrated Analysis of Safety/Efficacy Periodic Safety Update Report Post-Authorization Study occurs throughout occurs at specified intervals I N N O VAT I O N WE ARE DEDICATED TO MINIMIZING RISK AND PROTECTING PATIENT SAFETY • Investment protection • Meaningful products • Cost-effective safety services • Multiple levels of accountability • Global process improvement initiatives • Customized, holistic management solutions “Globally deployed, our teams deliver expert services with local knowledge. Our understanding of local cultures and their nuances helps us dig deeper and more effectively identify adverse events – some of which might go unreported without this awareness. We are committed to ensuring the highest levels of patient safety." SABINE RICHTER, VP, Safety & Risk Management • Comprehensive safety infrastructure • Nimble problemsolving approach • Sophisticated, versatile systems & data analysis Philadelphia USA Charlottesville USA • Global teams, local safety knowledge • Phase I-IV regulatory expertise • Highly experienced in pharmacovigilance standards & practices • Operational solutions & efficiencies • In-depth patient care & safety program • High-quality data Swansea UK Mannheim Germany S ingapore Asia São Paulo Brazil From the patients and their families who expect effective medicines, to sponsors striving to develop meaningful disease treatments, and finally to our team of professionals who tirelessly scrutinize these products to assure their safety – it’s all about people. PRA's global teams focus on product safety every day. While collecting and analyzing real-world data, we are mindful of the millions of people that our work touches. The skills and dedication of our scientists and safety experts are unparalleled – and patients deserve nothing less as we work to mitigate and minimize risk in the use of innovative therapeutic products. Pharmacovigilance demands more of us than just collecting the most comprehensive data and meeting the expectations of clients and health authorities. To fully understand what it takes to protect the public, we have to know and appreciate where they call home. Our people understand the nuances and foundations of each country’s culture, customs, and standards of medical practice. This knowledge enables us to make quality, ethically informed decisions that help keep patients safe. PRA PRA Health Health Sciences Sciences conducts conducts comprehensive comprehensive Phase phase I-IV I-IV biopharmaceutical biopharmaceutical drug drug development. development. To To learn learn more more about about our our solutions, solutions, please please visit visit us us at at prahs.com prahs.com or or email email us us at at [email protected]. [email protected].
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