Meet Scientific and Commercial Objectives in the midst of Increasing Payer and Regulatory Requirements
- Philadelphia, Pennsylvania
Discover why industry leaders have trusted CBI’s Post-Approval Series for more than a decade!
Post-approval studies continue to be an area of increasing importance given the payer power and regulatory requirements. There are many challenges associated with these studies including the changing landscape of quality oversight, subject recruitment, increasing data demands and so on. Attend this elite meeting to stay on the cutting-edge of information related to your post-approval studies.
Key conference highlights:
- Regulatory perspectives from FDA, NIH and Health Canada
- Phase IV monitoring
- “Operationalizing” post-approval studies to meet multiple objectives
- Innovative strategies for conducting global registries
- REMS – Lessons learned from the trenches
- Subject recruitment using innovative technologies
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Enhancing statistical analysis in post-approval studies
Don’t miss the opportunity to customize your congress and network with industry leaders within pharma, biotech, medical device, CRO and technology providers surrounding the latest post-approval studies challenges!
Global Foundation Sponsor and Invitation-Only Post-Approval Executive Summit Host:
At REGISTRAT-MAPI, we provide strategic and operational solutions for our clients in the design and implementation of Late Phase studies. REGISTRAT-MAPI is the pharmaceutical industry’s largest global CRO dedicated exclusively to real world clinical research. With more than 450 experienced professionals, REGISTRAT-MAPI has served the and medical device industries for more than 20 years. Our mission is to partner with our sponsors to conduct quality research, advance scientific knowledge, gain clinical insights and optimize the effectiveness and safety of medical products. REGISTRAT-MAPI is an established leader in navigating the complex and evolving landscape of global Late Phase research. With offices in Europe, North America and Asia, we will guide you through strategic and practical issues from project conceptualization and design, to global execution in the real world.
Prospective
• Registries (product, disease, pregnancy)
• Product Utilization Studies
• Late Phase Clinical Trials (IIIB-IV)
• Epidemiological Studies (pre-/peri-/post-approval)
• Patient Reported Outcomes
• Pharmacoeconomic Studies
• Post-Authorisation Safety Studies
• Risk Management Programs
• Expanded Access Programs
• Comparative Effectiveness Research
• Large Streamlined Trials
• PMAs/510Ks
Retrospective
• Database Studies
• Chart Reviews
Consulting
• Late Phase Design
• Regulatory
• Drug Safety
• Pharmacovigilance
Risk Management
• REMS
• EU-RMPs
• Data Analyses
• Evaluation
• Epidemiology
Service Outsourcing
• Epidemiology
• Programming & Biostatistics Safety
REGISTRAT-MAPI experts are your direct link to the latest views and solutions associated with Late Phase research. Our team is comprised of seasoned professionals with broad and deep knowledge. Importantly, that expertise is honed from hands-on involvement in the practical challenges of designing and managing Late Phase research. Contact us today!!
859-223-4334 • info@registratmapi.com • www.registratmapi.com
