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    Schedule GCP PPSG 2023

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    Sya Mohd
    This document provides the timetable for a GCP (Good Clinical Practice) workshop taking place from June 22-24, 2023 in a hybrid format. The workshop will cover topics such as clinical research principles in Malaysia, ethical issues in clinical trials, informed consent, adverse events reporting, and the roles and responsibilities of investigators, sponsors, and monitors. Speakers include professors and assistants from Universiti Sains Malaysia who will address topics each morning and afternoon over the three-day period.

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    Schedule GCP PPSG 2023

    Uploaded by

    Sya Mohd
    13 views3 pages
    This document provides the timetable for a GCP (Good Clinical Practice) workshop taking place from June 22-24, 2023 in a hybrid format. The workshop will cover topics such as clinical research principles in Malaysia, ethical issues in clinical trials, informed consent, adverse events reporting, and the roles and responsibilities of investigators, sponsors, and monitors. Speakers include professors and assistants from Universiti Sains Malaysia who will address topics each morning and afternoon over the three-day period.

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    SCHEDULE GCP PPSG 2023

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    This document provides the timetable for a GCP (Good Clinical Practice) workshop taking place from June 22-24, 2023 in a hybrid format. The workshop will cover topics such as clinical research principles in Malaysia, ethical issues in clinical trials, informed consent, adverse events reporting, and the roles and responsibilities of investigators, sponsors, and monitors. Speakers include professors and assistants from Universiti Sains Malaysia who will address topics each morning and afternoon over the three-day period.

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    © All Rights Reserved
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    13 views3 pages

    Schedule GCP PPSG 2023

    Uploaded by

    Sya Mohd
    This document provides the timetable for a GCP (Good Clinical Practice) workshop taking place from June 22-24, 2023 in a hybrid format. The workshop will cover topics such as clinical research principles in Malaysia, ethical issues in clinical trials, informed consent, adverse events reporting, and the roles and responsibilities of investigators, sponsors, and monitors. Speakers include professors and assistants from Universiti Sains Malaysia who will address topics each morning and afternoon over the three-day period.

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    of 3

    TIMETABLE FOR GCP WORKSHOP 22-24 JUNE 2023

    VENUE: HYBRID

    SCHOOL OF DENTAL SCIENCES, UNIVERSITI SAINS MALAYSIA.

    TIME 9.00-10.00 am 10.00-11.00 am 11.00-12.00 pm 12.00-1.00 pm 2.00-3.00 pm 3.00-4.00 pm


    DATE
    22 June 2023 Introduction to Clinical Research Principles of GCP Ethical issues & Informed Adverse Events
    (Thursday) GCP & GCP in Malaysia & Malaysian GCP Requirements in Consent GCP (Monitoring &
    Examination Guidelines Clinical Trial Form & Safety
    Certificate Violations Reporting)

    AP Dr Nazri Prof Dr. Liza Prof Dr. Azidah Prof Dr Lee Profesor Dato’
    Mustaffa Sharmini Ahmad Abdul Kadir Yeong Yeh Dr. Mafauzy
    Tajudin Mohamed AP Dr Wan
    Lunch Break Mohd Izani Wan
    1.00-2.00 pm Mohamed
    TIMETABLE FOR GCP WORKSHOP 22-24 JUNE 2023
    VENUE: HYBRID

    SCHOOL OF DENTAL SCIENCES, UNIVERSITI SAINS MALAYSIA.

    23 Jun 2023 GCP Inspections Good Laboratory Investigational 2.30 pm


    (Friday) & Audit Practice (GLP) Products (Supply
    Requirements and Handling, Small Group Case Discussion
    Accountability &
    Archiving) Role of investigator/sponsor
    Audit & Inspection findings
    Adverse Events
    Mr. Oh Chen Wei En. Mohd En. Raja Zaiful
    Nazman Bin Che Asyraf Bin Raja AP Dr Nazri Mustaffa
    Razak Deraman
    24 June 2023 Sponsor’s Monitor/CRO’s Regulatory Investigator’s GCP Assessment
    (Saturday) Responsibilities Responsibilities Aspects of responsibilities
    (Data (Audit & Clinical Trials in (Study design, Physical-F2F
    Management & Inspection) Malaysia Clinical Trials Conference Room & Seminar
    related issues) Protocol & Room PPSG
    Amendments
    Ms Iris Tan Guak Ms Iris Tan Guak Pn. Nursafira Investigator
    Wah Wah Binti Khiril Amir Brochures,
    Essential
    Document and
    related issues)

    AP Dr Azlan
    Husin
    TIMETABLE FOR GCP WORKSHOP 22-24 JUNE 2023
    VENUE: HYBRID

    SCHOOL OF DENTAL SCIENCES, UNIVERSITI SAINS MALAYSIA.

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