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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 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 | : | RM100.00 |
2 | Non UKM Participant | : | RM150.00 |
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. Zulkarnain Abdul Karim | 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 | Sponsor’ Responsibility (Section 5)
| En. Terence Lee Jia Shean
| Zoom |
15.30 – 16.30 | Quiz | Dr. Hajar Mohd Salleh Sahimi | 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)
| Prof. Dr. Mohd Shahrir Mohamed Said | Zoom |
10.00 – 10.15 | Break | ||
10.15 – 11.30 | Investigator’s Responsibility (GCP Chapter 4)
| Prof. Dr. Raja Affendi Raja Ali | Zoom |
11.30 – 12.30 | Quiz | Dr. Hajar Mohd Salleh Sahimi | 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, | |
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, |
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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