GCP – Clinical Investigation Centre

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.

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.

tentative program

Day 1

Day 2

Day 3

Day 1

Day 2

Day 3

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 Overview of Ethics Ethical issues on Clinical Trial
1145 – 1300	Clinical Trial Protocol Study Design Protocol Amendment
1300 – 1400	Lunch
1400 – 1500	Investigator’s Responsibility Compliance of Protocol Study Reports
1500 – 1630	Informed Consent Process Exercise on Informed Consent Process

DAY 2 – Virtual Session
0815 – 0915	Role of Study Coordinator (SC)
0915 – 1115	Sponsor’s Responsibility Role of the Monitor Handling of Investigational Products (IP) Drug Accountability and Archiving
1115 – 1215	Safety Monitoring and Reporting Adverse Events
1215 – 1230	Quizzes and Break
1230 – 1330	Lunch
1330 – 1445	Investigator Brochure (IB) and Essential Documents
1500 – 1630	Audit and Inspection

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

JOIN OUR GOOD CLINICAL PRACTICE (GCP) WORKSHOP!

good clinical practice

tentative program

GCP WORKSHOP DAY 1

GCP WORKSHOP DAY 2

GCP WORKSHOP DAY 3

gcp workshop 2020

gcp workshop 2019

Room Booking

eServices

iPesakit

Let's Connect !