Real-world Evidence A Saudi Regulatory Perspective
•Download as PPTX, PDF•
0 likes•76 views
By Mr. Turki A. Al-Thunian, Bpharm, MClinPharm, MSc.Epi, PhD, Acting Director of the Research Informatics Department, Saudi Food and Drug Authority (SFDA), delivered at the Global Forum 2020 Drug Safety and Supply Chains session.
More Related Content
What's hot
What's hot (20)
Similar to Real-world Evidence A Saudi Regulatory Perspective
Similar to Real-world Evidence A Saudi Regulatory Perspective (20)
More from UN SPHS
More from UN SPHS (20)
Recently uploaded
Recently uploaded (20)
Real-world Evidence A Saudi Regulatory Perspective
- 1. GLOBAL FORUM2020 3 R D S A V I N G L I V E S SU S T A I N A B L Y: SUSTAINABLE PRODUCTION IN THE HEALTH SECTOR GLOBAL FORUM | 2020 RIYADH Real-world Evidence: a Saudi Regulatory Perspective Turki A Althunian, Bpharm, MClinPharm, MScEpi, PhD Director of the SFDA Research Informatics Department Research and Laboratory Sector Vice-chair ISPE GRIG
- 2. INTRODUCTION Phasellus viverra nulla ut metus varius laoreet. Quisque rutrum. Aenean imperdiet. Etiam ultricies nisi vel augue. Curabitur ullamcorper ultricies nisi. Nam eget dui. Etiam rhoncus. Maecenas tempus, Matthews et al. Proteomes 2016 Drug development is subjected to strict and controlled experimentation prior approval!
- 3. INTRODUCTION Phasellus viverra nulla ut metus varius laoreet. Quisque rutrum. Aenean imperdiet. Etiam ultricies nisi vel augue. Curabitur ullamcorper ultricies nisi. Nam eget dui. Etiam rhoncus. Maecenas tempus, Forte G 2017 Assessing drug journeys in the market is a function of BIG DATA!
- 4. Big data in the regulatory context are best shaped by the routine clinical care Real-world data (RWD) Real-world evidence (RWE) “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” .. FDA “clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD ” .. FDA
- 5. “Never before in the history of medicines regulation, regulators have initiated platforms for ‘own data’ or extensive access data. Usually sponsors are required to deliver quality, pre-clinical, PK or clinical data ” .. Leufkens B 2020
- 6. RWE is not only for post-marketing safety assessment! RWE Effectiveness Safety Health policies Regulatory actions Shortage Repurposing
- 7. Point-of-dispense framework for SFDA/health policy assessment
- 8. Outcome-based models! Mahmoudpour et al. BJCP 2018
- 9. Complicated infrastructure! Generating RWE requires a multidimensional infrastructure from an establishment, maintenance & usage perspective GLOBAL FORUM 2020
- 10. Challenges in the Saudi context Alnofal et al. PDS 2019 • Adopting electronic health recording systems is relatively new • Separate recording systems within one hospital • Different hospitals use different coding systems and algorithms • Lack of validation studies • Data completeness?
- 11. 2018 ‘where it all started’ GLOBAL FORUM 2020 Establishing the National Saudi Pharmacoepidemiology Database
- 12. One structure/shape for all records! Alnofal et al. PDS 2019
- 13. OHDSI OMOP Common Data Model OHDSI
- 14. SFDA scientists can formulate any research question! OHDSI
- 16. Hierarchical validity exercise Validate the extraction Validate the conversion Validation study
- 17. Assessing the readiness for RWE 2020 Validation study I Step I Step II Step III Stakeholder I TEXT TEXT Stakeholder II Stakeholder III Effectiveness study Feasibility for advanced analysis I Feasibility for advanced analysis II Validation study II Regulatory science I Regulatory science II Study III Study III
- 18. RWE methodological testing experience started internationally
- 19. GLOBAL FORUM2020 THANK YOU Pharmacoepi team: Thamir Alshammari, PhD Fatemah Alnofal, MSc Meshael Alrasheed, PharmD Meshari Alsaleem, BSc Ghada Alsagari, BSc