Pengumuman

Assalāmu 'Alaikum Warahmatullāhi Wabarakātuh

Dear All IIUM Community,

We are pleased to invite you to participate in the Good Clinical Practice (GCP) Workshop 2019/1 as detailed below:

Normal Fee

Repeat Exam

The workshop aims that any clinical research you embark on is conducted in accordance with international ethical and scientific standards. 

Certificate of Achievement will be issued by the National Committee for Clinical Research, Ministry of Health Malaysia to participants who attend all sessions and pass the GCP examination after the workshop ends.   The GCP examination will be conducted by the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia.

Please RSVP by 1 March 2019 (Friday) as seats are limited to 50 participants and 10 participants for repeated examination.   Registration will be strictly on a first come first serve basis.  

Kindly fill in the online registration form https://goo.gl/forms/pJJN4inOL...

You may contact us if you require additional information or further clarification regarding this matter i.e. Br. A’imullah at 09-570 4733 (aimullah@iium.edu.my) or Sr. Atika at 09-570 4406 (atika@iium.edu.my) or Sr. Rosnida at 09-570 4410 (eiyda@iium.edu.my).

We look forward to meet you at the workshop. 

Thank you and Wassalāmu cAlaikum Warahmatullāhi Wabarakātuh

 “LEADING THE WAY”

PROF. DR. JAMALLUDIN BIN AB RAHMAN

Deputy Dean (Postgraduate & Research) cum

Chairman, GCP Workshop 2019/1

Kulliyyah of Medicine, IIUM

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Good Clinical Practice (GCP)

GCP is a set of rules and regulation that is provided by ICH, an international body that regulates clinical trials involving human subjects. It is a standard for the design, conduct, performance, monitoring, auditing, recording, analysing and reporting of clinical trials that provides assurance that the; Data and reported results are credible and accurate, and Rights, integrity and confidentiality of trials subjects are protected.

Why GCP?

In clinical trials, the protection of the subject is paramount especially when untested therapy is used. There must also be assurance about the conduct of clinical trials in terms of elimination of cheating, fraud or accidental error.   Problems of poor study design must be avoided.   Adherence to GCP is vital otherwise, subjects participating in the trials may be put at risk or the clinical trial data submitted may be rejected by health authorities and the scientific committee, if found to be unreliable. Also, the research credibility of the researcher and the research institution may be damaged.

Malaysia adopted GCP in 1999, and since then doctors are required to undergo training on GCP leading to certification prior to participation in clinical trials. This course is specifically designed to meet this requirement.

Objectives

·         To understand the principles underlying GCP and its specific rules of conduct.

·         To provide experience in the key skills required through simulation in classroom settings.

·         To provide some of the resources required to design and to conduct GCP trial.

·         To achieve an overall understanding of how to conduct GCP compliant clinical trial.

Who Should Participate?

Clinicians, nurses and allied health professionals involved with research, research associates and study coordinators, Biomedical and research scientists, statisticians and database managers, experienced research personnel who are interested in updating their knowledge regarding GCP.

Syllabus for NCCR Approved GCP Course 2017

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"LEADING THE WAY"

ATIKA MASNI BINTI ABD MALEK

Office Secretary

Office of the Deputy Dean (Postgraduate & Research)

Kulliyyah of Medicine

International Islamic University Malaysia

Bandar Indera Mahkota, 25200 Kuantan

Pahang Darul Makmur

Malaysia

Tel. No.:   609-570 4406

Fax No.:   609-571 6546