Advocating Good Clinical Practice with NUMed’s Inaugural GCP Workshop
Newcastle University Medicine Malaysia hosted a recent Good Clinical Practice (GCP) Workshop in collaboration with the Institute of Clinical Research Malaysia, National Institute of Health, and National Pharmaceutical Regulatory Agency.
13 November 2023
Newcastle University Medicine Malaysia (NUMed) hosted a Good Clinical Practice (GCP) Workshop recently. A joint effort with the Institute of Clinical Research Malaysia, National Institute of Health (ICR, NIH) and National Pharmaceutical Regulatory Agency (NPRA), the hybrid workshop was held from 1 - 3 November 2023.
The workshop, which was attended by 25 participants, marked the first time such an event was held at NUMed, establishing it as one of the institutes to offer GCP in the southern region of Peninsular Malaysia. Besides medical doctors and paramedics, the university saw an influx of scientists, research assistants, and researchers from both traditional and complementary medicine faculties during this time.
Among others, its goals encompassed encouraging NUMed academicians and researchers to gain GCP certification, promoting GCP certification to other institute researchers, clinicians, and scientists in the country, offering hassle-free access to GCP examinations in the southern region, and reaffirming the NUMed campus’s position as a world-class and safe environment for events.
The first two days of the event were conducted online, while the last day saw participants heading to NUMed to attend two final lectures before sitting for an exit exam. Those who completed all three days of the course were presented with an attendance certificate by NUMed. Additionally, medical doctors obtained 20 CPD points over the course of the three days, courtesy of the Malaysian Medical Association (MMA).
The workshop featured esteemed figures from the medical fraternity, namely Dr Azizan Sharif, Consultant Hematologist and Internal Medicine Physician from Hospital Sultanah Aminah, Johor Bahru; Dr (Mr) Henry Tan Chor Lip, General Surgeon from KPJ Bandar Dato Onn, Johor Bahru; Mr Muhammad Fahmi Yakop and Dr Haziq Aiman Kamal Bahri from MedCentral Consulting; as well as NPRA’s Principal Assistant Director Ms Safiya Mohd Razif and GCP Inspector Ms Fauziah Mohamed Kasim.
The topics they addressed included an Overview of GCP & Clinical Research in Malaysia, International Council of Harmonization (ICH): GCP versus Malaysian GCP, Ethical Issues in Clinical Trial, Clinical Trial Protocols, Investigator’s Responsibilities, Informed Consent Process, the Role of the Study Coordinator, Sponsor’s Responsibility, Safety Monitoring and Reporting, Investigator Brochure (IB) & Essential Documents, Audit Inspection, Regulatory Aspects of Clinical Trials in Malaysia, and Good Clinical Practice (GCP) Inspection.
Also on hand were Ms Zaitun Mohd Saman, Biostatistician and Pharmacist from Hospital Pakar Sultanah Fatimah, Muar, who was appointed to be the distinguished NUMed GCPW Certification Examination Invigilator, and Ms Nadia Hisamuddin, ICR GCP Secretariat from NIH Malaysia who provided valuable guidance.
Despite this being a first-time endeavour, the workshop was positively received, with a participant noting that “The NUMed GCP workshop was well-organised and very professional. It was well-balanced with personal space for consolidation.”
According to the Chairperson of the event, Dr Bhuwaneswaran Vijayam, “NUMed is a potential hub for clinical trials, research commercialisation, and science dissemination. The university strives to provide world-class education and pioneering research solutions to pressing world issues. The GCP course ticked all the boxes. I am proud to chair this inaugural workshop, which saw a strong committee go the extra mile, work hard, and make this event a success!”