DATE : 21st - 24th August 2017

COURSE FEE : RM1600

*Course fee does not include accommodation and transport

VENUE :   Animal Research Complex (ARC)

                    Advanced Medical and Dental Institute

                    USM Bertam Pulau Pinang

{tab=Day 1   21 August 2017}
0800 – 0900  :  Registration of Participants
0900 – 1000  :  Integrated Quality System Towards Medicine Development
1000 – 1030  :  Tea Break
1030 – 1130  :  Overview of Regulatory Safety Data for Herbal Medicine
1130 – 1300  :  Overview of Herbal Toxicity Testing
1300 – 1430  :  Lunch & Solat
1430 – 1530  :  Overview of Phytochemicals Standardization for Herbal Medicine
1530 – 1700  :  Overview of Regulatory Chemical Analysis of Herbal Product
1700 – 1730  :  Overview of OECD – GLP Document No. 1
1730 – 1800  :  Tea Break

* Each participant shall bring their own laptop to facilitate the use of electronic training notes

{tab=Day 2   22 August 2017}

0900 – 1000  :  Revisit Day One with Q&A Session
1000 – 1030  :  Tea Break
1030 – 1200  :  Role of Study Director under OECD – GLP
1200 – 1330  :  Example of GLP Compliant Study Plan and Study Report
1330 – 1430  :  Lunch & Solat
1430 – 1545  :  Overview of OECD Toxicity Test Guidelines
1545 – 1700  :  Overview of ICH Pharmacosafety Test Guidelines
1700 – 1730  :  Overview of Animal Model and Handling
1730 – 1800  :  Tea Break

* Each participant shall bring their own laptop to facilitate the use of electronic training notes

{tab=Day 3   23 August 2017}

0900 – 1000  :  Revisit Day Two with Q&A Session
1000 – 1030  :  Tea Break
1030 – 1130  :  Overview of Test Facility SOPs
1130 – 1300  :  Understanding the OECD GLP Principles Part 1: Section 2: Clause 4 to 10
1300 – 1430  :  Lunch & Solat
1430 – 1530  :  Common Deviations Found during GLP Inspection – Session I
1530 – 1630  :  Common Deviations Found during GLP Inspection – Session 2
1630 – 1730  :  Dialogue with NPRA & DSM “CMA Expectation and Acquiring Recognition for MAD status”
1730 – 1800  :  Tea Break

* Each participant shall bring their own laptop to facilitate the use of electronic training notes

{tab=Day 4   24 August 2017}

0900 – 1030  :  Overview Visit of GLP Test Facility Functional Rooms for In-vivo Toxicity Testing
1000 – 1030  :  Tea break
1030 – 1300  :  Demo of Verification of Testing Facility Fitness, Process & Records
                            :  Demo of Critical Phase: Marking of Test System, Oral Gavage Dosing & Observation
1300 – 1430  :  Lunch & Solat
1430 – 1600  :  Demo of Verification of Testing Facility Fitness, Process & Records
                            :  Demo of Critical Phase: Marking of Test System, Oral Gavage Dosing & Observation
1600 – 1700  :  Evaluation of Training Effectiveness
1700 – 1730  :  Tea Break

* Each participant shall bring their own laptop to facilitate the use of electronic training notes

{/tabs}

OECD GLP Intensive Course for Study Director of Test Facilities