Archives: Agenda
Afternoon refreshments and networking
Psychedelic Compounds in Clinical Trials: The Risks and Benefits of Video Recording Subjects
• Patient consent
• Patient safety and clinician accountability
• Data privacy, HIPAA, 21 CFR Part 11 and related guidelines and regulations
• Bias
• Education and research implications
Lunch and networking
Ensuring Adequate Sponsor Oversight of Clinical Trials When Outsourced to Clinical Contract Research Organisations
This presentation will highlight.
- Ensuring that KPIs are informative and meaningful.
- Assessing overall project risk and appropriate surveillance tactics
- Consolidating your overall management strategy that can be coordinated with CRO SOPs
- Providing documentation of Sponsor oversight activities throughout the study
Setting up Global Clinical Trials, with a focus on Asia Pacific
• Strategies for Country and Site Selection
• Optimizing cost and time
• Large and small company perspectives
• Leveraging global trial footprint to accelerate clinical development
• The evolution of Clinical Development in AsiaPacific
• How different notified bodies and their regulations present challenges to our clinical execution strategies