- Defining high-fidelity synthetic data
- MHRA approach to synthetic data generation
- Can synthetic data be used to validate ML algorithms?
- Can synthetic data be used for sample boosting?
- Can synthetic data address biases due to underrepresentation?
- Can synthetic data be used to enhance clinical trials (CTs)?
- Regulatory considerations
Archives: Agenda
Lunch and networking
Afternoon refreshments and networking
Lunch and networking
ROUNDTABLE SESSIONS
During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table lead/host and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.
ROUNDTABLE 1:
|
Kerri Fuller, Director, Resp/Imm/ID PM Operations, GSK
| ROUNDTABLE 2: Innovative approaches to support sites facilitate study implementation including EHR data mining, eISF, and SSO login |
Marie Lefebvre, Local Innovation Lead, Sanofi
| ROUNDTABLE 3: The role of lived experience in clinical trials: meaningful patient engagement in clinical trials is vital to develop impactful and relevant outcomes |
Cameron Keighron, Project Coordinator, International Diabetes Federation of Europe and Trials@Home consortium member, Patient Advocate
| ROUNDTABLE 4: MHRA draft guideline on the use of external control arms based on real-world data to support regulatory decisions
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Rebecca Ghosh, Real World Evidence Specialist, MHRA
| ROUNDTABLE 5: The EU CTR 536/2014, how is it going so far? Background, operational challenges, opportunities
|
Riccardo Ferraiuolo, Sr Manager – Clinical Trials Transparency, Biogen
Close of conference
SPONSOR AND SITE RELATIONSHIPS: Excellence in commercial research delivery: the London North West way
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PANEL DISCUSSION: Current operational challenges in running commercial clinical trials in the UK/IE: the need for increasing our attractiveness globally
| · Ambition for the UK and the current status
· Site set up: the need for research ready sites · Site recruitment: increasing our say do ratio |
Clinical trial investigations: looking at the trends and landscape for 2024 and what we can learn from them moving through 2025 and into 2026
- Overview of global clinical trials for 2024
- Assessing key sponsors, top interventions and looking at the trial landscape for 2024
- Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status
SMOs: The Hidden Engine of Japan’s Clinical Trials in Changing Times
Japan’s clinical research landscape offers a unique model, characterized by well-established processes such as the Site Management Organization (SMO) system, which plays a critical role in site selection and accelerating patient recruitment. Over the past five years, Japan has made significant strides in streamlining its regulatory pathways, with median new drug approval timelines now approaching parity with those of the U.S. FDA.
In this session, as Japan’s leading CRO and SMO, we will provide a quick overview of recent PMDA regulatory updates and deliver an in-depth view of how SMOs operate within Japan’s clinical trial ecosystem. Attendees will gain valuable insights into a proven model that enhances trial efficiency and support global development strategies.