Introduction to Practical Clinical Research and Clinical Trial Management

Event Date : 06/08/2016
Event Time : 8:30 am - 5:45 pm
Materials : Download PDF

This is a one-day course designed to enhance and improve core knowledge and practical insight related to Clinical Trial and Research Management. This course will provide a practical approach on the fundamentals of clinical research ranging from planning the development of the clinical trial to reporting requirements through the use of an interactive and practical case study methodology.


By the end of the course, you will be able to achieve the following learning objectives:

  • Understand the overall development plan of a clinical trial management
  • Understand your role and responsibility in clinical research and clinical trial management effectively and efficiently
  • Make data driven decision
  • Understand drug safety as a key component of clinical trial management

Keynote Speakers

  • Prof Dato’ Dr Anuar Zaini
    Professor of Internal Medicine at Jeffrey Cheah
    School of Medicine and Health Science, Monash University Malaysia
  • Prof Teng Cheong Lieng
    MBBS (Malaya), Master of Family Medicine (Malaya),
  • Jefferey Scott Yablon
    Vice President and General Manager (Asia-Pacific) at InClinica
  • Dr Khairul Faizi Khalid
    Head of Business Development, CRM
  • Dr Sulakshana Vijayakumar
    Dental Surgeon with Post Graduate Diploma in Clinical Research and Regulatory Affairs
  • Dr Yap Poh Sin
    PhD in Epidemiology from University of California

Who should attend?

Staff from government agencies, hospitals and pharmaceutical industries, researchers, students from local universities and research institutions.



Time Topic Instructor
0830-0845 Welcome and Introduction Jefferey Scott
0845-0930 Global Clinical Research Environment: Issues and
Jefferey Scott Yablon
0930-1015 Regulatory Guidelines: ICH, GCP, EMA, PBFK Dr
Khairul Faizi Khalid
1015-1030 Break
1030-1130 Understanding and Interpretation of the Protocol Prof Dato’ Dr Anuar Zaini
1130-1300 Networking Lunch
1300-1330 Case Study Prof Dato’ Dr Anuar Zaini
1330-1415 Type of Trial: Different PhasesCase Studies
on the Clinical Problem Solving Methodology
Prof Teng Cheong Lieng
1415-1445 New Development of Clinical Trial: Adaptive Clinical
Trial and Risk Based Monitoring
Dr Yap Poh Sin
1445-1530 Data Management and Surrogate Endpoints Source Data
Dr Vijayakumar
1530-1545 Break
1545-1630 Case Study Dr Vijayakumar/Dr Yap Poh Sin
1630-1730 Drug Safety and Pharmacovigilance: AE/SAE Reporting
and Triage Lab-Altered Values
Jefferey Scott Yablon
1730-1745 Conference Close Jefferey Scott Yablon

 Registration Fee   (All fees inclusive GST 6%)

Regular RM850
Early bird (before 30 June 2016) RM680
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