PURPOSE: To debate whether new and emerging policies and guidance on the use of real-world evidence (RWE), should be focusing on harmonisation between regulatory and Health Technology Assessment (HTA). Through interactive discussions and real-time polling, we seek to identify the benefits and opportunities of harmonisation, but also the challenges and hindrances this could pose in regard to future policy development.

DESCRIPTION: In recent years, there has been an increasing number of policies on the use of RWE within regulatory and HTA healthcare decision-making. As more policies emerge with differing methods and recommendations, it raises the question of whether there is a greater need for harmonization between policy for regulators and HTA? Differing organizational remits of regulators and HTA agencies will likely place some limits on harmonization, but to what extent should there be a drive to harmonize other elements including between medicines and MedTech? Does harmonization support future RWE policy development or will it hinder efforts to develop policy by encouraging guidance that is too broad and non-specific?

In this workshop, Rita Peeters will introduce the topic by discussing the evolution of RWE policies across regulatory/HTA organisations (10 minutes). Katharine Cresswell will discuss the context of the Innovative Health Initiative - Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance (IHI-IDERHA) project and what degree of harmonization was found in their recent global review of these policies (10 minutes). Patrice Verpillat will provide the regulatory perspective discussing perceived gaps and opportunities for future development and harmonization (10 minutes). Niklas Hedberg will discuss the HTA perspective and where harmonization may be challenging (10minutes).

A 20-minute interactive audience discussion, facilitated by real-time polling will allow discussion of critical arguments for and against harmonisation, and priority areas for future policy. Poll results will be displayed, allowing participants to see points of consensus and differentiation.