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    Malaysian Guideline for Application of Clinical Trial Import ...

    um.edu.my
    https://mohre.um.edu.my › files › MALAYS_2
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    https://mohre.um.edu.my › files › MALAYS_2
    European Commission Detailed guidance forthe request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use ...

    prevention and control of infectious diseases act 1988

    um.edu.my
    https://mohre.um.edu.my › files › PREVEN_1
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    https://mohre.um.edu.my › files › PREVEN_1
    Citation and commencement. 2. Interpretation. 3. Importation and exportation of human remains or any part thereof. 4. Importation and exportation of human ...

    postgraduate handbook 2021/2022

    um.edu.my
    https://mohre.um.edu.my › PG_Book_20212022
    um.edu.my
    https://mohre.um.edu.my › PG_Book_20212022
    1 Dec 2021 — You are entering the next phase of your higher education at a challenging time. The world has undergone significant changes due.
    296 pages

    Malaysian Guideline for Phase I Unit Inspection & ...

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    Clinical Research Centres and Universities. Dr Goh Pik Pin. Dr Kalai Peariasamy. Dr Alan Fong Yean Yip. Ms Lee Len Tiong. Mr Chew Chun Keat.

    peraturan-peraturan peranti perubatan 2012 medical ...

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    31 Dec 2012 — “pelabelan” adalah suatu istilah yang digunakan bagi merangkumi semua bahan bertulis, bercetak atau grafik yang dikemukakan oleh pembuat ...

    MALAYSIAN NATIONAL MEDICINES POLICY

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    https://mohre.um.edu.my › files › buku-dunas
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    https://mohre.um.edu.my › files › buku-dunas
    ACKNOWLEDGEMENTS iii. PREAMBLE. 1. INTRODUCTION. 1. 1. GOVERNANCE IN MEDICINES. 4. 1.1 AIM. 5. 1.2 STRATEGY. 5. 2. QUALITY, SAFETY AND EFFICACY OF MEDICINES.

    Medical Device Act 2012 - laws OF MalaYsIa

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    30 Jan 2012 — Requirement for establishment licence. 16. Application for establishment licence. 17. Additional information or document.

    BULLETIN - Master of Health Research Ethics (MOHRE)

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    The MOHRE Bulletin is an annual publication by the MOHRE Programme,. Faculty of Medicine, Universiti Malaya. The views and opinions expressed by the.
    14 pages

    mohre bulletin

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    The Masters of Health Research Ethics. (MOHRE) is a one of a kind programme in. Malaysia that we are very proud to conduct together with our colleagues from ...
    30 pages

    Occupational Safety and Health Act 1994 (Act 514)

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    15 Feb 1994 — Section 39. Powers of entry, inspection, examination, seizure, etc. Section 40. Entry into premises with search warrant and power of seizure ...

    a randomized study of prison-based methadone ...

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    by R Saifi — A RANDOMIZED STUDY OF PRISON-BASED METHADONE MAINTENANCE. THERAPY. Rumana Saifi, PhD. Globally, prevalence of HIV and associated infections is significantly ...

    laws of malaysia - act 366 poisons act 1952 (revised

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    agricultural operations of any kind are carried on or upon which the produce of any plants or trees is collected or treated or any mine to which the ...

    MOHRE Brochure 2022.pdf

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    The Master of Health Research Ethics. (MOHRE) degree programme is the offspring of an exciting collaboration between the Faculty of.
    2 pages

    A Guide To Conducting Clinical Trials in Malaysia

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    1 Apr 2015 — The total drug discovery and development market size in the top seven Asian countries was estimated at $5.3 billion in 2011 and is forecast ...

    Act 678: Biosafety Act 2007 - LAWS OF MALAYSIA

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    29 Aug 2007 — Requirement for approval. 13. Application for approval. 14. Director General to refer application to Advisory Committee, etc.

    Dangerous Drugs Act 1952

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    17 Jul 1980 — Restriction on importation of raw opium, coca leaves, poppy-straw and cannabis. 5. Restriction on exportation of raw opium, coca leaves, ...
    80 pages

    Scholarship - Master of Health Research Ethics (MOHRE)

    um.edu.my
    https://mohre.um.edu.my › doc
    um.edu.my
    https://mohre.um.edu.my › doc
    The Master of Health Research Ethics. (MOHRE) degree programme is the offspring of an exciting collaboration between the Faculty of.
    2 pages

    Class Schedule

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    SEM 1 (OCT- FEB). Day Time. Course. Mon. Tue. 200pm-500pm. Research Ethics in Special Populations. Wed 900am-1200pm. Healthcare Law and Ethics (Electives).

    poisons-psychotropic-substances-regulations-1989. ...

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    2 Mar 1989 — (a) any person arriving in or leaving Malaysia who carries as part of his personal luggage and solely for his personal use or for the use of ...

    Updated Research Standard in Malaysia.pdf

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    NIH: National Institutes of Health (NIH). Guidelines For Conducting Research. In Ministry Of Health Institutions And. Facilities 2015.
    10 pages

    Casebook on Health Research Ethics in Southeast Asia ...

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    Introduction: The University of Malaya Faculty of Medicine (Malaysia) and Johns Hopkins Berman Institute of Bioethics (USA) are seeking case submissions ...
    2 pages

    NEW Guideline on Online Application.pdf

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    Click “Search Now”. Next: • For Malaysian, please click “MASTER OF HEALTH RESEARCH ETHICS (SCWMQFFTCV0001/. SCWMQFFTCV01)”. • For Non-Malaysian or Permanent ...
    8 pages

    Biosafety (Approval and Notification) Regulations 2010

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    (2) The Director General may, at any time after the receipt of an application under subregulation (1), require the approved person to provide him any ...

    Act 130 Human Tissues Act (1974) - LAWS OF MALAYSIA

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    Removal of parts of bodies for therapeutic purposes. 2. (1) If any person, either in writing at any time or orally in the presence of two or more witnesses ...

    Malaysian Phase I Clinical Trial Guidelines

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    Abbreviations. Foreword. List of expert panel members. 1: Introduction. 2: Developing a new medicine. 2.1. First-in-Human trial. 2.2. Subsequent trials.

    Medical Genetics and Genetic Services MMC Guidelines

    um.edu.my
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    In this Guidelines, the words “doctor”, “physician”,. “medical practitioner” and “practitioner” are used interchangeably, and refer to any person registered ...

    Malaysian Guideline for Good Clinical Practice

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    8 Mar 2018 — The National Committee for Clinical research (NCCR) has commissioned the update of the Malaysian Guideline for Good Clinical Practice ...

    National Organ, Tissue and Cell Transplantation Policy

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    3 Apr 2007 — Special gratitude to Dato' Dr Zaki Morad Mohamad Zaher, the former Head of. Nephrology Department, Kuala Lumpur Hospital who later joined ...

    Biosafety Guidelines Risk Assessment Of Genetically ...

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    1.1 Scope. 1.2. Definitions. 1.3 Format for risk assessment. 1.4 Overall nature of hazards posed by the intended GMM. 1.5 Risk assessment for human health.

    ACT 368 SALE OF DRUGS ACT 1952 (REVISED - 1989)

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    “officer” means any Medical Officer of Health of the Medical Department of the Federal Government or of any State Government or of the Health Department of ...

    National Standards for Cord Blood Banks

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    Stem cell technology, especially from cord blood, has gained national interest in view of its potential in effectively treating.

    Guideline for Stem Cell Research and Therapy

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    Stem cells have a tremendous potential in terms of therapy. However, many of these therapies, especially those involving replacement and repair of tissues ...

    Standard Operating Procedure For Transport Of Biological ...

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    The purpose of developing this Standard operating procedure is as a reference for. Ministry of Health Malaysia hospital laboratories.

    Compliance to PDPA: a quick guide

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    1)A relevant person in relation to a data subject,. 2)A data processor; or. 3)A person authorized in writing by the data user to process the.

    Prevention and Control of Infectious Diseases Act 1988

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    "airport" means any area of land, water or space designed, equipped, set apart or commonly used for affording facilities for the take-off and landing of ...

    Malaysian Guidelines on the Use of Human Biological ...

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    It is my hope that with the launch of these guidelines all stakeholders are clear on how we handle human biological samples, with the foremost aim of ...

    Guidelines for Ethical Review of Clinical ...

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    The authority to exempt a proposed research from MREC review and approval may be delegated to an individual or body in the local institution. For MOH.

    LAWS OF MALAYSIA

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    3 Sept 2009 — (c) in relation to a person in whom there is a condition of arrested or incomplete development of mind or body.

    national pharmaceutical control bureau

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    21 Jan 2016 — Development of biological medicines has been extremely rapid and the potential of such products for improving health care on a global scale ...

    NIH GUIDELINES FOR CONDUCTING RESEARCH IN ...

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    These Guidelines describe Ministry of Health (MOH) policies governing the conduct of research in MOH institutions and facilities. The policy statements in.

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