This workshop provides a focused and practical overview of essential elements required for initiating clinical trials. The session will cover three key areas:
a) Preclinical data requirements for clinical trial applications,
b) The different categories of clinical trials, and
c) Common myths and pitfalls that may hinder trial integrity and execution.
Participants will gain practical insights into study planning, and real-world challenges in clinical trial implementation. This workshop is ideal for investigators, sponsors, and research teams aiming to enhance their trial readiness and conduct high-quality research.
SPEAKER
Mr. Chew Chun Keat
Mr Chew Chun Keat (CK) is the Technical Head at the Centre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, and a Fellow at the International Vaccine Institute. He played a key role in establishing one of Malaysia’s two NPRA-accredited First-in-Human (FIH) trial centers at Hospital Ampang. The centre has since led and conducted numerous trials, including bioavailability, bioequivalence, vaccine efficacy, drug delivery systems, and drug-drug/food-drug interaction studies.
CK is a board member of the Medical Research and Ethics Committee (MREC) under the Ministry of Health. He also contributed to the enhancement of pharmacovigilance oversight in clinical trials through the development of an online platform for reporting Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR).
He actively supports the World Health Organization (WHO) in alignment with the World Health Assembly’s direction on strengthening national and regional clinical trial ecosystems. He has served on expert panels and working groups involved in the development of key national guidelines, including the Malaysian Guideline for Phase 1 Unit Inspection & Accreditation Programme, Malaysian Phase 1 Clinical Trial Guideline, and A Guide to Conducting Clinical Trials in Malaysia.
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