Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 6: Panel Discussion (2018)
In this session, audience members ask the panel questions concerning real world evidence, the gold standard for devices, adaptive trial design, sample size of control group, and legislation changes in European drug regulations.
Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 5: Case Studies and Future Trends (2018)
In this session, we will discuss trends in drug development in 2017 and look at case studies that reflect these trends.
Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 4: Unique Designs for Medical Device Trials (2018)
In this session, we will discuss how medical device trials are conducted in Europe and the United States and how these trials differ from pharmacological trials.
Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 3: Classic and Novel Designs Used in Regulatory Approvals (2018)
In this session, we will discuss how classic and novel designs are used in regulatory approvals and the benefits and consequences of utilizing these types of designs.
Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 2: Evolution of FDA’s View of a Well-Designed Clinical Trial (2018)
In this session, we will discuss how to conduct an effective clinical trial from the perspective of the FDA.
Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 1: Intro/Key Terms (2018)
In this session, we will discuss commonly used terms in clinical trial design and regulatory science.