Archives: Agenda

An overview of high-fidelity synthetic data applications

  • 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

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:

Enhancing Site Feasibility and Analytical Lab Testing: Strategies for Effective Communication and Sample Integrity

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

 

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