APEC Harmonization Center Workshop:
Post-Pandemic Regulatory Environment Changes in Clinical Trials
October 23rd – 24th, 2023 | COEX at Seoul, Korea (Hybrid format)
Description: The COVID-19 pandemic has transformed the global regulatory environment, accelerating the use of innovative measures & regulatory flexibility to support development of safe, quality medical products in timely manner. In clinical trials, use of decentralized clinical trials (DCTs) became more and more relevant, highlighting the critical benefits of virtual trials and recruitment of diverse patient population while lowering the burden. Digital Technologies also brought significant improvements, enabling real-world data collection outside the traditional clinical context.
As such, this 2-day hybrid workshop will explore how the pandemic catalyzed the regulatory changes in clinical trials with focus on the use of DCTs and Digital Technologies by examining its current regulatory landscape and discussing future opportunities & challenges.
| Day 1 : October 23rd (Mon) | |||
|---|---|---|---|
| Time | Topic | Speaker | |
| Welcome and Introduction | |||
| 09:00 - 09:05 | Welcoming Remarks | Jeewon Joung (AHC) | |
| Session 1: How Pandemic impacted Global Regulatory Environment | |||
|
09:05-09:25 (20min) |
Setting the Scene: - COVID-19 Pandemic’s impact in global regulatory environment; How it catalyzed use of regulatory flexibility & innovative measures in clinical trials |
Sumitra Sachidanandan (HSA) |
|
| Session 2: Decentralized Clinical Trials | |||
|
09:25-09:50 (25min) |
Deep Dive into Decentralized Clinical Trials (DCTs) - Overview on DCTs & its recent trend: evolution of DCT concept, key aspect, benefits, etc. Q&A (5min) |
Yvanka Maria Gilliam (SCRI) |
|
|
09:50-10:20 (30min) |
Current Regulatory Landscape for DCTs - Introducing regulatory frameworks DCT, Lessons learned, benefits, challenges, etc. • Chinese Taipei Q&A (5min) |
Yi-Hsuan Hsu (TFDA) |
|
|
10:20-10:50 (30min) |
Practitioner perspectives on DCTs - Experience sharing & Case Study: Practical considerations in using DCTs • Practitioner (Hospitals, CROs) Q&A (5min) |
Jiyeon Park (SNU Hospital) |
|
| 10:50-11:00 | Closing Day 1 | ||
| Day 2 : October 24th (Tues) | |||
|---|---|---|---|
| Time | Topic | Speaker | |
|
09:00-09:30 (30min) |
Quality Risk Management for DCTs - Using Risk-Based Monitoring (RBM) strategies in DCT - Maintaining regulatory compliance in DCTs Q&A (5min) |
Lilith Hayakawa Mist (Merck) |
|
|
09:30-10:00 (30min) |
Data Management and Analysis in DCTs - Data Quality & Integrity: Ensuring reliable and accurate data collection - Statistical Considerations in DCTs: Addressing potential biases and limitations Q&A (5min) |
Aparajeeta Priyadarasini (Medidata) |
|
|
10:00-10:30 (30min) |
Future of DCTs: Regulatory Opportunities & Challenges | Kwunho Jeong (JNP MEDI) |
|
| Session 3: Digital Technology in Clinical Trials | |||
|
10:30-11:00 (30min) |
Application of AI in Drug Development | Eun Young Park (AinB) |
|
|
11:00-11:10 |
Wrap Up & Closing | AHC | |
