Introduction to Practical Clinical Research and Clinical Trial Management

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.
OBJECTIVES
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),
FRACGP, FAFPM, FAMM - 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.
REGISTRATION FEE COURSE PROGRAMME
Programme
Time | Topic | Instructor |
0830-0845 | Welcome and Introduction | Jefferey Scott Yablon |
0845-0930 | Global Clinical Research Environment: Issues and Opportunities |
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 Verification |
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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