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2. Methods of payment.
a) Online Transfer / ATM :-
b) Local Order (Pesanan Kerajaan)
Please upload softcopy of Local Order (LO) in registration form and bring the original document on the day of registration.
c) International Transfer :-
COMPANY NAME : UNIVERSITI KEBANGSAAN
MALAYSIA
ADDRESS : 279 Jalan Perkasa 1,
Taman Maluri,
55100 Kuala Lumpur
Malaysia
COMPANY REGISTRATION NO : PU (A) 105
BANK ACCOUNT NO : 8600081140
SWIFT CODE : CIBB MYKL
BANK BRANCH : CIMB Islamic Berhad
Cawangan Taman Maluri
BANK ADDRESS : 279 Jalan Perkasa 1,
Taman Maluri,
55100 Kuala Lumpur
Malaysia
COMPANY EMAIL : zkkc@ppukm.ukm.edu.my
CONTACT : +603-91455287
Note :
1. Participants who failed the examination in the previous workshop must register as repeat participants if either the duration from the last workshop they attended has exceeded three (3) years, or the participants have failed to meet the requirement of the attendance in the previous workshop.
2. Withdrawal from the workshop and Fee Refund: The registration fee will not be refunded if the participant withdraws after the registration’s closing date. Withdrawal during the workshop is not allowed. All decisions made by the GCP Workshop Committee on any issues that arise during the workshop are final.
For further inquiries, please contact 03-9145 9498 (Mrs. Siti Noorain Hamid) or 03-9145 9480 (Mr. Khaidir Hashim)
or email: bengkelsppi@ppukm.ukm.edu.my
New application | |||
1 | UKM Participant | : | RM400.00 |
2 | Non UKM Participant | : | RM550.00 |
Repeat participant | |||
1 | UKM Participant | : | RM350.00 |
2 | Non UKM Participant | : | RM500.00 |
Exam only | |||
1 | UKM Participant | : | RM50.00 |
2 | Non UKM Participant | : | RM75.00 |
Note :
1. Participants who failed the examination in the previous workshop must register as repeat participants if either the duration from the last workshop they attended has exceeded three (3) years, or the participants have failed to meet the requirement of the attendance in the previous workshop.
2. Withdrawal from the workshop and Fee Refund: The registration fee will not be refunded if the participant withdraws after the registration’s closing date. Withdrawal during the workshop is not allowed. All decisions made by the GCP Workshop Committee on any issues that arise during the workshop are final.
TIME | PROGRAM | SPEAKER | VENUE |
Moderator: Assoc. Prof. Dr. Nik Ruzyanei Nik Jaafar | |||
08.30 – 08.45 | Registration | ||
08.45 – 09.00 | Welcome speech by the chairman | Assoc. Prof. Dr. Nik Ruzyanei Nik Jaafar | Zoom |
09.00 – 10.00 | Overview of ICH/ GCP and Malaysian GCP Guideline (GCP Chapter 2) & ICH/ GCP and Malaysian GCP Guideline Compared | Prof. Dr. Ima Nirwana Soelaiman | Zoom |
10.00 – 10.15 | Break | ||
10.15 – 11.15 | Oversight & Funding for Clinical Research in MOH – Role of NIH, MREC, MOH Guidelines for Clinical Research and MOH Research Grant | Dr. S. Asmaliza Ismail | Zoom |
11.15 – 13.00 | Clinical Trial Protocol & Investigator’s Brochure | En. T. Mahendran | Zoom |
13.00 – 14.00 | Break | ||
Moderator: Assoc. Prof. Dr. Suria Hayati Md Pauzi | |||
14.00 – 15.30 | Investigator’s Responsibility (GCP Chapter 4) – Qualifications & CTA (4.1) – Adequate Resources (4.2) – Medical Care of trial Subjects (4.3) – Communications with IRB/IEC (4.4) – Study Intiation & patients Recruitment – Compliance with Protocol (4.5) – Randomization & Unbliding (4.7) – Case Report Form Completion and Source Documents Records, Report & Essential Documents (4.9, 4.10, 4.13 & Chapter 8) – Investigational Product (IP) Accountability at Site (4.6) – Role of a Site Coordinator Group Discussion – Role & Responsiblities of Investigator, IRB/IEC and Sponsor | Prof. Dr. Raja Affendi Raja Ali
| Zoom |
15.30 – 16.30 | Quiz | Dr. Luke Woon Sy-Cherng | Zoom |
TIME | PROGRAM | SPEAKER | VENUE |
Moderator: Assoc. Prof. Dr. Nurasyikin Yusof | |||
08.30 – 09.00 | Registration | ||
09.00 – 10.00 | Overview of Ethics of Clinical Research, Ethical Principles & Requirements (Helsinki Declaration) – Independents Ethics Committe – Ethical Problems in Clinical Research | Prof. Dr. Mohd Shahrir Mohamed Said | Zoom |
10.00 – 10.15 | Break | ||
10.15 – 11.30 | Sponsor’ Responsibility (Section 5 & 8) – QA and QC (5.1) – Trial Management, data Handling, Record Keeping (5.5) & Access (5.15) – Selection of Investigator / Site (5.6) – Allocation of Responsibilities (5.7) – Compesation to Subjects, Investigators & Financing (5.8 & 5.9) – Notification to Regulatory & Submission to IRB/IEC (5.10 & 5.11) – Information on IP, Manufacturing, Packaging & Labelling IP, and Supplying and Handling IP (5.12, 5.13 & 5.14) – Study Monitoring (5.18) – Audit & Inspection (5.19 & 5.20) – Premature Termination (4.12 & 5.21) – Multicentre Trial (5.23) – Archiving (5.15) | En. Terence Lee Jia Shean | Zoom |
11.30 – 12.30 | Quiz | Dr. Luke Woon Sy-Cherng | Zoom |
12.30 – 14.00 | Break | ||
Moderator: Prof. Dr. Mohd Shahrir Mohamed Said | |||
14.00 – 15.00 | Adverse Event Reporting & Safety Surveillance (Sect.4.11 & 5.17) Group Discussion – Adverse Event Reporting & Safety Surveillance | En. Syed Putra Muharis | Zoom |
15.00 – 16.00 | Informed Consent & Patient Information Sheet (GCP Section 4.8) | Prof. Dr. Shamsul Azhar Shah | Zoom |
TIME | PROGRAM | SPEAKER | VENUE |
08.00 – 08.20 | Registration | Exam Hall A, | |
08.20 – 09.20 | GCP Inspection | Ms. Melissa Lim Ven Ching | |
09.20 – 10.20 | Regulatory Aspects of Clinical Trial in Malaysia | Representative from NPRA | |
10.20 – 11.00 | Breakfast & Preparation for exam | ||
11.00 – 12.00 | Good Clinical Practice Examination | Representative from NPRA | Exam Hall A, |
12.00 – 12.15 | Prize giving for Quiz | ||
12.15 – 13.00 | Lunch/Closing | ||
Monday to Thursday
8:00 am – 1:00 pm
2:00 pm – 5:00 pm
Friday
8:00 am- 12:15 pm
2.45 pm – 5:00 pm
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