clinical research malaysia (1006282-x ... - ministry of healthhqe.moh.gov.my/web/ict/gcp refresher...
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Clinical Research Malaysia (1006282-X) Address: Suite E-10-20, Amcorp Business Suites Menara Melawangi, Amcorp Trade Centre, No. 18, Jalan Persiaran Barat, 46050 Petaling Jaya, Tel: 603-79605153; Fax: 603-79321940
2 November 2016 Pengarah,
Jabatan Kesihatan Negeri Sabah, Hospital Queen Elizabeth, Hospital Queen Elizabeth II, Hospital Wanita
& Kanak-kanak Sabah, Hospital Mesra Bukit Padang, Hospital Duchess Of Kent Sandakan, Hospital
Beaufort, Hospital Beluran, Hospital Keningau, Hospital Kinabatangan, Hospital Kota Belud, Hospital
Kota Marudu, Hospital Kuala Penyu, Hospital Kudat, Hospital Kunak, Hospital Labuan, Hospital Lahad
Datu, Hospital Papar, Hospital Pitas, Hospital Ranau, Hospital Semporna, Hospital Sipitang, Hospital
Tambunan, Hospital Tawau, Hospital Tenom, Hospital Tuaran, Kolej Sains Kesihatan Bersekutu Kota
Kinabalu
Pegawai Kesihatan Kawasan
PKK Kota Kinabalu, PKK Penampang, PKK Beluran, PKK Beaufort, PKK Keningau, PKK
Kinabatangan, PKK Kudat, PKK Lahad Datu, PKK Sandakan, PKK Tawau, PKK Tuaran
Dekan
Fakulti Perubatan dan Sains Kesihatan, Universiti Malaysia Sabah
Pengerusi Eksekutif
Sabah Medical Centre, Rafflesia Medical Centre, Damai Specialist Centre.
Y.Brs. Dr, SURAT JEMPUTAN MENGHADIRI BENGKEL GOOD CLINICAL PRACTICE REFRESHER WORKSHOP DI HOSPITAL QUEEN ELIZABETH, KOTA KINABALU Dengan segala hormatnya perkara di atas adalah dirujuk. 2. Sukacita dimaklumkan bahawa Clinical Research Malaysia (CRM) berkolaborasi dengan Pusat Penyelidikan Klinikal (CRC) akan menganjurkan bengkel tersebut di atas. Berikut adalah butiran maklumat bengkel tersebut: Nama Bengkel : Good Clinical Practice Refresher Workshop Tempat : Hospital Queen Elizabeth, Kota Kinabalu Tarikh : 19hb November 2016 (8.30 pagi – 5.30 petang) Jumlah Peserta : 20 orang peserta 3. Untuk makluman, tujuan bengkel ini diadakan adalah untuk para penyelidik yang berhasrat untuk menjalankan penyelidikan klinikal. Bengkel ini dikhususkan untuk penyelidik yang telah menyertai kursus Good Clinical Practice (GCP) sebelum ini. 4. Semua perbelanjaan menganjurkan bengkel ini akan dibiayai sepenuhnya oleh pihak CRM manakala pihak CRC akan membantu dalam urusan persediaan, penyertaan peserta, pendaftaran peserta serta urusan penyediaan makan dan minum peserta. Untuk makluman tuan / puan, segala kos dari segi pengangkutan dan penginapan sepanjang kursus ini diadakan adalah di bawah tanggungjawab PTJ masing-masing.
Clinical Research Malaysia (1006282-X) Address: Suite E-10-20, Amcorp Business Suites Menara Melawangi, Amcorp Trade Centre, No. 18, Jalan Persiaran Barat, 46050 Petaling Jaya, Tel: 603-79605153; Fax: 603-79321940
5. Bersama-sama ini kami lampirkan sesalinan brosur mengenai maklumat lanjut bengkel untuk rujukan pihak tuan / puan selanjutnya. Sila lengkapkan penyertaan menggunakan borang pada brosur yang dilampirkan bersama dan faks ke nombor 088-435734/088-211906 atau emel ke [email protected]/ [email protected]. Mohon kerjasama pihak tuan/puan agar menghubungi 088-522600 ext 2272 (Roslin) atau 088-517507 (Alvin) bagi memastikan borang penyertaan telah diterima oleh pihak sekretariat. 6. Kerjasama dan sokongan pihak Tuan/Puan didahului dengan ucapan ribuan terima kasih. Sekian. “BERKHIDMAT UNTUK NEGARA” Yang benar, DR AKHMAL YUSOF Ketua Pegawai Eksekutif Clinical Research Malaysia (1006282-X)
General Objective
To understand the principles underlying GCP and its specific rules of conduct.
To provide experience in the key skills required through simulation in classroom setting.
To provide some of the resources required to design and to conduct GCP trial.
To achieve an overall understanding on how to conduct GCP compliant clinical trial.
WHO SHOULD PARTICIPATE?
1) Doctors who are GCP certified 2) Have not been actively involved in clinical trials
REGISTRATION Registration Fees = No Registration Fees The course includes all supporting documentation, course materials, refreshment and lunch. CANCELLATION
Any cancellation must be made in writing to the organizer.
We reserve the right to change the date(s) or speaker (s) of this course, if deem fit, without prior notice.
We further reserve the right to cancel the GCP Refresher course
REGISTRATION FORM Name: Prof / Dr / Mr / Mrs / Ms ________________________________________________________________________ (Please print name in block letters as you wish it to appear in the certificate)
IC / Passport No:
Department:
Institution:
Designation:
______________________________
______________________________
______________________________
______________________________
Contact
Address:
Contact No:
Email:
______________________________
______________________________
_______________________( office)
_______________________(mobile)
_______________________(Fax)
______________________________
Vegetarian meals required: No Yes
How would you rate your experience as an Investigator:
Beginner Moderate Expert
Is there any ongoing and/or upcoming ISR at you site?
Upcoming Ongoing
Mr Alvin Bundoi, Secretariat
Tel : 088-517507 / Fax: 088-211 906 Email: [email protected]
Mrs Roslin Guadih, Secretariat
Tel : 088 522 600 ext 2272 / Fax: +6088 435 734 Email: [email protected]
FOR FURTHER ENQUIRIES, PLEASE CONTACT
Clinical Operations GCP Refresher Program 19 November 2016 V1.0 dated 4 August 2016 Page 1 of 1
GOOD CLINICAL PRACTICE (GCP) REFRESHER PROGRAM
19 November 2016
8.30 am – 5.30 pm
Venue: Bilik Seminar 3, Hospital Queen Elizabeth, Kota Kinabalu
This course is a revision of Good Clinical Practice (GCP) principles and processes for all clinical
trial investigator who have previously attended GCP training. The course is interactive and
discussion around current issues is encouraged. For your information, sponsors prefer all study
personnel to have refresh their knowledge and renew their GCP certificates every 3 years.
TIME ACTIVITIES & AGENDA
(DISCUSSION / PRESENTATION / TRAINING)
SPEAKER
8.10 AM – 8.30 AM Registration
8.30 AM – 9.00 AM Welcome address from Clinical Research Centre (CRC)
9.00 AM – 10.30 AM Introduction and revision on ICH GCP Wong Sok Yee
10.30 AM – 11.00 AM Tea Break
11.00 AM – 12.00 PM Investigator’s responsibilities
12.00 PM – 1.00 PM Sponsor’s Responsibilities
1.00 PM – 2.00 PM Lunch
2.00 PM – 3.00 PM Informed Consent
3.00 PM – 3.30 PM Group exercise
3.30 PM – 3.50 PM Tea Break
3.50 PM – 4.50 PM Role of IRB/IEC
4.30 PM – 5.30 PM Group Exercise
5.30 PM Adjourn