This year’s programme offers an exceptional line-up that navigates the intricate landscape of Real World Evidence (RWE) in Regulatory and Health Technology Assessment (HTA) decision-making
On the first day, May 14th 2024, join us for invaluable insights from regulatory giants, as they unravel the critical role of RWE. We will be hosting HTA representatives in a debate style with a focus on the preparedness of utilising RWE when the HTA Regulation comes into effect, and learning from their practical experiences of applying RWE methods for decision-making.
On the second day, May 15th 2024, we will take a deep-dive on RWE methods being applied by regulatory and HTA bodies in the use of external control arms, the implementation of common data models, and the pragmatic and decentralised approaches of future trials.
Our keynote will take you on a journey of a vision of the future where we have accelerated the convergence of RWE within and between regulatory and HTA bodies to provide better evidence in submissions, quickly resolve uncertainties to ensure patients can access medical interventions.
Cue the grand finale, our “Regulatory & HTA Town Hall”, where we “GetReal” about the practical steps forward and for all stakeholders to share their voice in advancing the acceptability of RWE. Please note, this programme will continue to be updated.
14 MAY 2024
Session | Time |
---|---|
Registration & Welcome Coffee | 08:00 – 09:00 |
#1a. Opening Remarks | 09:00 – 09:15 |
#1b. Fireside Chat “Throw back” to last year, how is regulatory and HTA converging?
| 09:15 – 10:30 |
Coffee Break | 10:30 – 11:00 |
#2 What does good look like? Progress in Regulatory Decision Making with RWE RWE in regulatory decision making on guidance and use cases. How do we get there collectively, as a community? What progress are we making? What does good look like in RWE? What are the steps in-between?
| 11:00 – 12:30 |
Lunch & Networking | 12:30 – 14:00 |
#3 The Big Debate: This house believes we are making good progress towards adopting RWE as part of the HTA Regulation What progress are European HTAs making in adopting RWE and how is this benefitting patients?
| 14:00 – 15:30 |
Coffee Break | 15:30 – 16:00 |
#4 Deploying methods in HTA: the experiences of HTA bodies using RWE methods Which RWE methods are HTA bodies using and why? Are some easier to use than others? What do stakeholders say? Do some give more robust answers? What is their experience? What are the barriers?Examples and HTA methodology approaches straight from the horse’s mouth
| 16:00 – 17:30 |
Networking cocktail | 17:30 – 19:00 |
15 MAY 2024
Session | Time |
---|---|
Welcome Coffee | 08:30 – 09:00 |
Opening Remarks | 09:00 – 09:05 |
#5a Methods Deep-Dive: A Scientific Discussion on RWE Methods Being Applied
| 09:05 – 10:20 |
Coffee Break | 10:20 – 10:50 |
#5b Methods Deep-Dive: A Scientific Discussion on RWE Methods Being Applied
| 10:50 – 12:05 |
Lunch | 12:05 – 13:20 |
#6 KEYNOTE: A Vision For The Future: What If We Accelerate The Convergence of Regulatory & HTA?
| 13:20 – 14:20 |
Coffee Break | 14:20 – 14:50 |
#7 CLOSING DISCUSSION: Regulatory & HTA Town Hall An opportunity for all voices to be heard. What are the needs, and are these complementary or competitive?
| 14:50 – 16:20 |
Final Remarks | 16:20 – 16:30 |