In today’s fast-changing regulatory environment, Real World Evidence (RWE) surrounding Safety, Comparative effectiveness and Outcomes have become a critical part of the Medical affairs and pre-commercialization strategy. As a result, we have noticed RWE being incorporated into shaping the clinical development strategy. However, when entering new markets or regions, it is important to recognize key challenges to generate fit-for-purpose evidence and learn how to overcome these barriers.

The session, tailored for the emerging biopharma, covers the following key objectives:

• Benefits and key considerations of incorporating an evidence strategy earlier in the product lifecycle
• Understanding various use cases for RWE ranging from regulatory submissions, HTA, pricing and reimbursement
• Strengthening product value proposition in US, EU and APAC
• Coverage on US, China, and APAC Real-world Data landscape
• Understanding alternative and faster access to RWE data strategies and key considerations with respect to timeline, cost, and operational execution to enable faster, more efficient evidence generation for real-world studies