Name: Navigating the Future of Clinical Trials
Start: 2025-01-22T15:00:00+08:00
End: 2025-01-22T17:00:00+08:00
Location: Ng Teng Fong Centre for Healthcare Innovation (CHI)

Join us as we explore the exciting possibilities and challenges in the ever-evolving world of clinical trials!
About this Event

📅 Mark Your Calendars: Navigating the Future of Clinical Trials: Understanding the draft Annex 2 document of the ICH E6 (R3) Good Clinical Practice (GCP) guideline

🗓 22 January 2025, Wednesday

⏰ 3:00 PM – 5:00 PM (3:00 – 4:30 PM for the session and 4:30 – 5:00 PM as networking)

📍 Ng Teng Fong Centre for Healthcare Innovation (CHI) Auditorium, Level 4

18 Jalan Tan Tock Seng, Singapore 308443

The clinical trial landscape is evolving rapidly, and with the upcoming ICH E6(R3) Good Clinical Practice (GCP) guideline, the global standards for clinical trials are set to be transformed.

Once published, the revised ICH E6 (R3) GCP guideline will comprise the following documents:

Principles document
Annex 1 – Considerations for Interventional Clinical Trials
Annex 2 – Additional Considerations for Interventional Clinical Trials

Join us for an insightful forum, where we will delve into the draft Annex 2 document, focusing on additional GCP considerations for interventional clinical trials and explore their implications for the future of clinical research.

🔍 What to Expect:

This forum, led by Ms Sumitra Sachidanandan, Regulatory Consultant from the Health Sciences Authority (HSA), will focus on:

✔️ Insights into the draft Annex 2 document, addressing additional GCP considerations for interventional clinical trials, including decentralised elements, pragmatic elements, and Real World Data.

✔️ Practical guidance on adopting a risk-proportionate and fit-for-purpose approach to ensure that the quality and amount of information generated in a clinical trial should be sufficient to support good decision making

✔️ Live FAQ session to address your burning questions.

This forum is a must-attend for clinical research professionals seeking to stay ahead of the curve as we collectively navigate the evolving regulatory landscape and integrate modern practices into clinical trial conduct. Whether you’re a seasoned professional or new to the field, this forum will provide valuable knowledge and practical tools to help you align your trial processes with these new global standards.