With current market complexity and a shifting regulatory landscape, Real World Evidence (RWE) is playing an increasing role in healthcare decisions and becoming essential to evaluate a drug’s long-term effectiveness and safety. Non-interventional studies (NIS) can be a suitable tool to generate RWE to support product life cycle development and improve decision making for all stakeholders, however, it is necessary to ensure data quality and adequate management of potential bias.
This webinar aims to share insight on key aspects to ensure the success of non-interventional studies. Throughout the session, our experts will discuss on how to deliver NIS efficiently and with quality, paying special attention to one of the most important aspects in this regard: bias management. Additionally, the audience will have the opportunity to learn about the RWE scenario in Japan with an overview of the regulatory framework and a review of several case studies.
Register to learn how to maximise non-interventional studies and generate evidence in post-approval setting.
Key Learning Objectives
- Get insight on keys to ensure the success of non-interventional studies
- Learn about optimal management of Bias when planning and conducting NIS
- Find out how to maximise non-Interventional studies in Japan
