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National Heart Centre Singapore

Lecture Theatre , Level 8

5 Hospital Drive

Singapore, Singapore 169609

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Theme :

Building Quality Risk Management Approaches and Ensuring Compliance in the Conduct of Clinical Trials: Implications from ICH GCP E6 (R2)

Synopsis:

With ICH GCP E6 (R2) now requiring risk-based approaches to managing quality in clinical trials, this session focuses on the critical elements included in the ICH GCP E6 (R2) expectations. This include expectations of QRM in relation to ICH GCP E6 (R2) and risk management plan to be adopted by the industry sponsors. Practical steps to ensuring GCP compliance for the conduct of Investigator Initiated Trials (IITs) will also be shared.

*Please note that the forum agenda is subject to changes without prior notice.

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Date and Time

Location

National Heart Centre Singapore

Lecture Theatre , Level 8

5 Hospital Drive

Singapore, Singapore 169609

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