Session Schedule

Wednesday, March 22nd Thursday, March 23rd Friday, March 24th

Time Event

San 09:00 - 09:45 #S0001-SL: Opening Plenary and Keynote Address

Francisco
(L3) 09:45 - 10:15 #S0002-L: Panel Discussion: Innovation Focus

10:45 - 12:15 #DMD01-L: EU Regulatory Townhall: EMA’s Strategic Focus Areas For 2023 – Advancing
Health Priorities
Montreal 10:45 - 12:15 #DMD02-L: WHO Townhall - WHO's Regulatory Systems Strengthening Program, WLA,
(L2) WHA75.8 Clinical Trials Strengthening and Paediatric Activities
13:30 - 14:40 #S0401-L: Will the Revised General EU Pharma Legislation Deliver on Innovation to
Patients?
15:10 - 16:20 #S0402-H: Will Europe Continue to Foster the Development of Orphan and Paediatric
Medicines?
17:00 - 18:30 #DMD03-H: RWE In Regulatory Decision-Making: State Of The Art 2023

Singapore 13:30 - 14:40 #S0201-H: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development
(L2)
15:10 - 16:20 #S0202-H: An Evolving Global Landscape: Shaping the Future of Decentralised Clinical
Trials
17:00 - 18:30 #DMD06-H: Antimicrobial Resistance – We Need to Act Together Now to Stop the “Silent”
AMR Pandemic!
Sydney (L2) 13:30 - 14:40 #S0802-L: Cloud Submissions – an Accumulus Case Study: Making it Work for All Players

15:10 - 16:20 #S0801-H: Dynamic Regulatory Assessment – A Key Initiative to Future Proof the EU
Regulatory Ecosystem
17:00 - 18:30 #DMD05-L: International Collaboration: Reliance in Action

Boston 1-2 12:20 - 13:20 #SPS02-L: Digital Health, Medical Devices & Artificial Intelligence: Crossing Innovation &
(GF) Regulatory Perspectives.
13:30 - 14:40 #S0601-L: Tech Development and Innovation in PV

15:10 - 16:20 #S0104-L: Demystifying AI and Machine Learning For Non-technical Stakeholders – A
Practical Session
Delhi (GF) 12:20 - 13:20 #SPS01-L: Connecting Data Beyond Patient Safety: Drive Deeper Insights To Minimize
Avoidable Harm and Optimize Treatment Outcome
13:30 - 14:40 #S0501-H: Implementing Significant Changes To Drug-Device Combination Products
Under EU MDR
15:10 - 16:20 #S0710-H: Latin America Townhall - Cooperation and Collaboration: What’s next for Latin
America?
17:00 - 18:30 #DMD04-L: HTA Townhall

Kairo 1-2 13:30 - 14:40 #S0701-L: Middle East Townhall - Building on the New Regulatory Agilities that the COVID-
(GF) 19 Pandemic brought to the Middle East Region
15:10 - 16:20 #S0706-H: Turkiye Townhall: Challenges and Opportunities For a Maturing Regulatory
Authority
Shanghai 1- 13:30 - 14:40 #S0702-L: MHRA Townhall
2 (GF)
15:10 - 16:20 #S0703-H: China Townhall: Building Innovation Ecosystem to Advance Drug R&D and
Accelerate Approval – Regulator, Industry and Academia Viewpoint
Lima (GF) 13:30 - 14:40 #PD01-H: Chat With Professionals – Career Twists and Turns

15:10 - 16:20 #PD02-L: Leadership Skills: Empowering Change in the Health Sector

16:30 - 18:00 #SPS07-L: Start-Up Village Session

Innovation 10:20 - 10:40 #IH01: The Rising Need for Performance and Diversity Insights for Clinical Ops and
Hub 1 (L1) Development Teams
12:20 - 13:20 #P01: Live Oral Poster Presentations I

14:45 - 15:05 #IH03: Clinical Research Perceptions Among Patients and the Public: Key European
Trends
Innovation 10:20 - 10:40 #IH02: Generative AI for Regulatory Submissions
Hub 2 (L1)
14:45 - 15:05 #IH04: Patient Centricity or Operational Excellence? Say YES to automated processes that
improve experiences
16:30 - 16:50 #IH06: DIA Research on Patient Engagement

Exhibition 10:15 - 10:45 Coffee Break

Hall (L1)
12:15 - 13:30 Lunch Break

14:40 - 15:10 Coffee Break & Speed Networking

16:20 - 17:00 Coffee Break

18:30 - 19:30 Welcome Reception