
GOOD CLINICAL PRACTICE 2019
(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.
Objectives
- To ensure that clinical research in Malaysia is conducted in accordance with international ethical and scientific standards.
- To understand the principles underlying GCP and its specific rules of conduct.
- To ensure that research subjects are protected.
- To ensure data arising from clinical research is of high quality.
GCP WORKSHOP DECEMBER 2018
GCP WORKSHOP 03-05 JULY 2018
GCP WORKSHOP DAY 1
0800 – 0830 |
Registration |
0830 – 0930 |
Overview of GCP and Clinical Trials and Overview of IGH GCP and its difference from the Malaysian GCP |
0930 – 1000 |
Tea |
1000 – 1100 |
Ethics and the IRB/IEC
|
1100 – 0100 |
Clinical Trial Protocol & Investigator’s Brochure |
0100 – 0200 |
Lunch |
0200 – 0400 |
Informed Consent Process |
0400 – 0430 |
Tea |

GCP WORKSHOP DAY 2
0800 – 0830 |
Registration |
0830 – 0930 |
Investigator’s Responsibility |
0930 – 1000 |
Tea |
1000 – 1100 |
Role of Study Coordinator (SC) |
1100 – 1200 |
Working with Sponsor |
1200 – 0100 |
Safety Monitoring and Reporting |
0100 – 0200 |
Lunch |
0200 – 0400 |
Audit and Inspection |
0400 – 0430 |
Tea |

GCP WORKSHOP DAY 3
0800 – 0830 |
Registration |
0830 – 0930 |
Specific Legal Issues in Relation to Clinical Trials |
0930 – 1000 |
Tea |
1000 – 1100 |
Regulation of Clinical Research in Malaysia |
1100 – 1230 |
Self preparation for GCP Examination |
1230 – 0200 |
Lunch |
0200 – 0300 |
Multiple Choice Question Examination for GCP Certification |


GOOD CLINICAL PRACTICE WORKSHOP 2017
1) 07-09 MARCH 2017
2) 01-03 AUGUST 2017
3) 10-12 OCTOBER 2017
4) 05-07 DECEMBER 2017
GOOD CLINICAL PRACTICE (GCP) WORKSHOP
OBJECTIVES
- To ensure that clinical research in Malaysia is conducted in accordance with international ethical and scientific standards.
- To understand the principles underlying GCP and its specific rules of conduct.
- To ensure that research subjects are protected.
- To ensure data arising from clinical research is of high quality.
