Late Phase Research/Real-World Data

Available for $495.00

For more than a decade, industry leaders have trusted the Center for Business Intelligence to provide the latest updates and strategies for conducting Late Phase and Post-Approval Studies.  Recently, the metrics by which payers, regulators and other stakeholders assess the value and safety of pharmaceutical products has shifted, placing a heightened emphasis on real-world evidence.  Under the increasing pressure to provide effectiveness data, pharmaceutical companies are tasked with the complex challenge of collecting, managing and analysing real-world evidence. Recognising the importance of cross-functional collaboration toward this goal, the Center for Business Intelligence is bringing together its Late Phase Research Summit and Real-World Data Summit into one unique forum.

9^th Annual Late Phase Research

Design Post-Approval Studies to Meet Critical Scientific, Safety, Risk Management, Regulatory and Commercial Needs

• Incorporate epidemiological methods into post-marketing study design to support safety assessments
• Bolster patient safety through compliant adoption of the new pharmacovigilance legislation
• Strategies for developing an effective and comprehensive risk management plan
• Utilise real-world research in a post-market setting to maximise the product value proposition
• Ensure information transparency for early safety detection of late phase studies

Real World Data

Utilise Observational, CER and Secondary Data to Support Product Value, Safety and Market Access

• Examine the key outcomes and stakeholder needs driving the expansion of real-world studies in drug development
• Big Data - industry partnerships and sourcing strategies for maximising patient health benefits with secondary data
• Understand the escalating impact of real-world evidence on coverage and reimbursement decisions
• Utilise electronic health record (EHR) data to support post-authorisation activities
• Observational and comparative effectiveness study design tactics