The conference will focus on the importance of real-world evidence and the need to amend the existing healthcare regulation regarding use of RWD / RWE in the clinical setting.

KEY POINTS

• Growing interest in the wider use of RWD in Europe and the US
• Augmenting clinical research data with RWD / RWE is becoming increasingly important as it helps to allocate limited healthcare resources and plan budget costs effectively
• The conference will be attended by the leading experts in clinical research, HTA, PHv, analysts dealing with Big Data, representatives of pharma, patient organizations, MoH and regulatory agencies

  TOPICS FOR DISSCUSSION

• RWD: the existing challenges
• RWD as an efficient tool for informing clinical guidelines
• Clinical Patient Registries: Is there a need for regulatory change?
• New proposals for digital healthcare worked up by State Duma
• Role of clinical pharmacology
• Routine clinical practice research: a clinician's perspective
• RWD as the basis for Federal Digital Technologies Project
• Regulation governing collection of RWD: examples offered by EU and the US
• RWD to support safety and efficacy decisions
• Outlook for personalized medicine
• RWD in EEU: prospects and opportunities
• Role of RWD from patient perspective

The conference will be held offline with a possibility to connect to online platform (a link to the platform will be forwarded to all participants by email). Also, an expo titled "RWD / RWE: Opportunities and Outlook" will be offered to participants.

For more detailed information please contact Alexander Ivanov at a.ivanov@aston-health.com, or +7 (916) 669-73-39