GCP
JOIN OUR GOOD CLINICAL PRACTICE (GCP) WORKSHOP!

good clinical practice
(ENDORSED BY THE MINISTRY OF HEALTH MALAYSIA)
This workshop is recommended for Clinical Researchers, Nurses, Pharmacist, Trial Monitors, Research Associates, Research Managers, Postgraduates candidates involved in clinical studies and other health professionals.
GCP Certificate will be provided to the qualifying candidates upon passing the examination.
GCP Certificate will be provided to the qualifying candidates upon passing the examination.
OBJECTIVES
tentative program
Day 1
Day 2
Day 3
Day 1
GCP WORKSHOP DAY 1
DAY 1 – Virtual Session | |
0800 – 0830 | Welcoming and Briefing |
0815 – 0915 | Overview of GCP and Clinical Research in Malaysia |
0915 – 1015 | International Council of Harmonization (ICH): GCP Compared to Malaysian Guideline for GCP |
1015 – 1130 | Ethics and the IRB/IEC
|
1145 – 1300 | Clinical Trial Protocol
|
1300 – 1400 | Lunch |
1400 – 1500 | Investigator’s Responsibility
|
1500 – 1630 | Informed Consent Process Exercise on Informed Consent Process |

Day 2
GCP WORKSHOP DAY 2
DAY 2 – Virtual Session | |
0815 – 0915 | Role of Study Coordinator (SC) |
0915 – 1115 | Sponsor’s Responsibility
|
1115 – 1215 | Safety Monitoring and Reporting
|
1215 – 1230 | Quizzes and Break |
1230 – 1330 | Lunch |
1330 – 1445 | Investigator Brochure (IB) and Essential Documents |
1500 – 1630 | Audit and Inspection |

Day 3
GCP WORKSHOP DAY 3
DAY 3 – Physical Session (PAUM Clubhouse) | |
0800 – 0830 | Registration |
0830 – 0920 | Regulatory Aspects of Clinical Trials in Malaysia |
0930 – 1020 | GCP Inspection |
1020 – 1130 | Self-Preparation for Examination |
1130 – 1230 | GCP Certification Exam |
1230 – 1300 | Lunch and End |

gcp workshop 2020







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