GCP – CIC

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.

We invite you to join our GCP 2019 on:

09-11 April

25-27 June

27-29 August

15-17 October

03-05 December

Download GCP Brochure

GCP WORKSHOP DECEMBER 2018

GCP WORKSHOP 03-05 JULY 2018

Day 1

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 Overview of Ethics Ethical issues on Clinical Trial
1100 – 0100	Clinical Trial Protocol & Investigator’s Brochure
0100 – 0200	Lunch
0200 – 0400	Informed Consent Process
0400 – 0430	Tea

Day 2

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

Day 3

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

(Endorsed by the Ministry of Health Malaysia)

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 Certificate will be provided to the qualifying candidates upon passing the examination.

This workshop is organized by CIC four times in a year.

For more information please contact:

The SECRETARIAT
Tel : 03 – 7949 2886 or 7949 2351
Fax : 03 – 7954 1904