PHILADELPHIA, June 02, 2015 — Experts from Premier Research will examine how regulatory changes are affecting clinical trials and medical device makers when they chair two sessions at the DIA 2015 51st Annual Meeting, June 14-18 in Washington, DC.
Meet us at the annual Drug Information Association meeting (booth 1711) and attend these informative sessions:
Changes in Regulations That May Impact How Inspections Are Conducted: Regulatory Perspectives. Wednesday, June 17, 8 a.m. to 9:30 a.m.
Sherri Hubby, Senior Director for US Quality Assurance at Premier Research, chairs a session where regulators from the US, Europe, and Japan will discuss changes that could affect how inspections are conducted, and the impact on sponsors, study sites, and contract research organizations. Learn about new guidance for inspection of the electronic Trial Master File and electronic records and about pre-inspection activities, inspection pre-announcements, risk criteria, reportable observations, and other topics.
Enhanced Collaborative Strategies: FDA and Device Makers Focusing on Improved Device Clearance Processes. Wednesday, June 17, 3:30 p.m. to 5 p.m.
Amnon Talmor, Premier Research Senior Regulatory Specialist and Global Medical Device and Compliance Lead, hosts a session about how the FDA has increased its involvement with device makers to improve mechanisms for product review and market clearance. You’ll learn about historical and legislative catalysts for improved communication and accountability between the FDA and device makers, and about newly adopted industry standards.
While at DIA 2015 visit booth 1711 and learn how Premier Research experts are meeting the needs of biotechnology, pharmaceutical, and medical device companies worldwide.
About Premier Research
Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.