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  Members of NCCR

The current composition of the NCCR was established to ensure that it becomes visionary and pro-active in driving the development of clinical research in the country.

The committee is made up of member representatives and experts from the Ministry of Health (MOH), various national Universities, the Malaysian Pharmaceutical Society (MPS), the Pharmaceutical Association of Malaysia (PhAMA), the Malaysian Organisation of Pharmaceutical Industries (MOPI), as well as other Non-Governmental Organisations. The composition of the member representatives reflects the on-going “smart-partnerships” amongst the various stake-holders with interests in quality clinical research in Malaysia.

The current NCCR committee members are:

  1. Director-General of Health Malaysia as the Chairperson;
    Tan Sri Dato' Seri Dr Noor Hisham bin Abdullah
    Ketua Pengarah Kesihatan
    Kementerian Kesihatan Malaysia
    Aras 12, Blok E7, Kompleks E,
    Pusat Pentadbiran Kerajaan Persekutuan,
    62590 Putrajaya.
  2. Deputy Director-General of Health (Research and Technical Support);
    Dr Hishamshah Bin Mohd Ibrahim
    Timbalan Ketua Pengarah Kesihatan Malaysia
    (Penyelidikan dan Sokongan Teknikal),
    Aras 12, Blok E7, Kompleks E,
    Pusat Pentadbiran Kerajaan Persekutuan,
    62590 Putrajaya.
  3. Chairman of Medical Research & Ethics Committee, Ministry of Health;
    Dr Salina Abdul Aziz
    Pengerusi,
    Jawatankuasa Etika & Penyelidikan Perubatan,
    Kementerian Kesihatan Malaysia,
    d/a Institut Pengurusan Kesihatan,
    Blok B1, Kompleks NIH,
    Jln Setia Murni U13/52,
    Seksyen U13, Setia Alam,
    40170, Shah Alam.
  4. Director of National Institute of Clinical Research, Ministry of Health;
    Dr. Kalaiarasu M. Peariasamy
    Pengarah,
    Rangkaian Pusat Penyelidikan Klinikal,
    Kementerian Kesihatan Malaysia,
    d/a Institut Pengurusan Kesihatan,
    Blok B1, Kompleks NIH,
    Jln Setia Murni U13/52,
    Seksyen U13, Setia Alam,
    40170, Shah Alam.
  5. Network of Ethical Review Committees in Malaysia (NERCIM) Representative;
    Prof. Normala Ibrahim,
    Faculty of Medicine & Health Sciences,
    Faculty of Medicine,
    Universiti Putra Malaysia 43400 Serdang,
    Selangor.
  6. National Stem Cell Ethics and Research Sub-committee (NSCERT) Chair;
    Professor Datuk Dr. A. Rahman A. Jamal
    Pengarah,
    Institut Perubatan Molekul,
    Universiti Kebangsaan Malaysia,
    Jalan Yaakob Latiff, Bandar Tun Razak, Cheras,
    46000 Kuala Lumpur.
  7. Director of National Pharmaceutical Regulatory Agency (NPRA);
    Dr. Hasenah Binti Ali
    Pengarah Bahagian Regulatori Farmasi Negara,
    Lot 36 Jalan Universiti,
    46200 Petaling Jaya, Selangor.
  8. University Representative (Private);
    Profesor Dato? Paduka Dr. Khalid Hj. Yusoff
    Naib Canselor dan Presiden,
    UCSI University,
    No. 1, Jalan Menara Gading,
    UCSI Heights, Cheras,
    56000 Kuala Lumpur.
  9. University Representative (Public);
    Assoc. Prof. Dr. Zamri Bin Chik
    Department of Pharmacology,
    Faculty of Medicine,
    University of Malaya,
    50603 Kuala Lumpur.
  10. Representative of Malaysian Pharmaceutical Society (MPS);
    MPS President and/or secretariat
    Profesor Dr. Yeoh Peng Nam
    International Medical University,
    No. 126, Jalan 19/155B, Bukit Jalil,
    57000 Kuala Lumpur.
  11. Representative of Pharmaceutical Association of Malaysia (PhAMA);
    PhAMA, C-18-02, 3 Two Square, (Dataran 3 2),
    No. 2, Jalan 19/1,
    46300 Petaling Jaya, Selangor.
  12. Representative of Malaysian Organisation of Pharmaceutical Industries (MOPI);
    Global Busineess & Convention Centre
    Mezzanine Floor, Block A, No. 8, Jalan 19/1, Section 19,
    46300 Petaling Jaya, Selangor Darul Ehsan
  13. Representative of Contract Research Organisation (Local);
    Dr. Sarojini Sivanandam
    Klinsel Sdn Bhd
    Suite 16.03, 16th Floor, IGB Plaza (known as Plaza Permata),
    No. 6, Jalan Kampar off Jalan Tun Razak,
    50400 Kuala Lumpur.
  14. Representative of Contract Research Organisation (Foreign);
    Lyca Manembu
    IQVIA (formerly known as Quintiles Malaysia Sdn Bhd)
    Suite D-08-02 Plaza Mont' Kiara,
    No.2 Jalan Kiara,
    50480 Mont Kiara,
    Kuala Lumpur.
  15. Chief Executive Officer (CEO) of Clinical Research Malaysia (CRM);
    Dr. Akhmal Yusof
    D-26-06, Menara Suezcap 1,
    KL Gateway, No. 2 Jalan Kerinchi,
    Gerbang Kerinchi Lestari,
    59200 Kuala Lumpur.
  16. Secretary of National Committee for Clinical Research, Ministry of Health
    Dr Zaril Harza Zakaria
    National Pharmaceutical Regulatory Agency
    Ministry of Health Malaysia
    Lot 36, Jalan Universiti,
    46200 Petaling Jaya
    Selangor

Various Sub-committees are formed to facilitate the work and operations of the NCCR. These include:

•  Sub-committee on “Site Visit” for Clinical Research Infrastructure
This committee was established to identify the strengths and weaknesses of the present research centres infrastructure, and to take necessary actions in improving them so that clinical research can be carried out in Malaysia
•  Sub-committee for “Guidelines for Application to Conduct Drug-Related Clinical Trials in Malaysia”
Guidance for researchers and the pharmaceutical industries who are interested in conducting clinical research in Malaysia
•  Sub-committee for “Good Laboratory Practice” (GLP)
This committee was established to develop the Good Laboratory Practice (GLP) Guidelines and organise courses related to it
•  Sub-committee for Bio-Equivalence Studies (BE)
The “ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies” which was prepared by Malaysia based on the "Malaysian Guidelines for the Conduct of Bioavailability and Bioequivalence Studies" was adopted by ASEAN with minor changes during the 8th ACCSQ PPWG Meeting in Bangkok, July 2004
•  Sub-Committee for Clinical Trial Import Licence
Guidance for researchers and the pharmaceutical industries who wish to import investigational products which are not registered in Malaysia for clinical research.
•  Sub-Committee for Good Clinical Practice (GCP) Training Courses
This committee was established to develop the curriculum and requirement for conducting NCCR accredited GCP training courses in Malaysia.

 

 



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