Good Clinical Practice
Workshop 2025

18th & 19th June  2025 • Zoom
20th June 2025 • In person • Newcastle University Medicine Malaysia

Newcastle University Medicine Malaysia (NUMed) is proud to organise the Good Clinical Practice (GCP) Workshop for the third time in the southern region of Malaysia. We welcome you to NUMed, a branch campus of Newcastle University in the UK, recognised for its world-class research and education, as well as its renowned ambience.

GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. It also serves to protect the rights, integrity, and confidentiality of trial subjects. These principals are in line with the World Medical Association’s (WMA) Declaration of Helsinki of 1964. With the increasing number of clinical trials conducted in the country, it is important to ensure trial subjects are protected and data integrity is preserved.

In Malaysia, GCP compliance is a requirement for all researchers working with human subjects, animals, or tissue in any part of their research. They must adhere to the highest international ethical and scientific standards while also considering national issues and local realities without compromising these standards. Currently, the Ministry of Health Malaysia is decentralising training and research activities to grant more autonomy to universities and clinical research centres.

Reserve Your Spot Now !

Full Course
+ Exam

For Non MOH Staff
<br>/person
800


/person

*Limited to 50 participants only.

Full Course
+ Exam

For MOH Staff Only
<br>/person
650


/person

*Limited to 50 participants only.

Full Course
+ Exam

For NUMed Staffs
<br>/person
300


/person

**Exclusive offer for NUMed staff only!

Exam
Only

Exam day only pass
<br>/person
150


/person

*Important Notice
• No refunds will be granted after 18th May 2025.
• Refund requests should be submitted in writing to: [email protected]
• Workshop registration may be cancelled with a full refund provided written notification is received at any time by 18th May 2025.
• In the case of an emergency/extenuating circumstances, special requests may be considered on a case-by-case basis by the GCP secretariat committee.

Important Notice
• No refunds will be granted after 18th May 2025
• Refund requests should be submitted in writing to: [email protected]
• Workshop registration may be cancelled with a full refund provided written notification is received at any time by 18th May 2025.
• In the case of an emergency/extenuating circumstances, special requests may be considered on a case-by-case basis by the GCP secretariat committee.

Closing Date To Register : 18th May 2025 at 11:59PM

Registration Countdown

Days
Hours
Minutes
Seconds

Event Schedule

Dive into the details of our meticulously crafted agenda, designed to cover every aspect of Good Clinical Practice (GCP).

Welcoming Exam & CPD Briefing

Overview of GCP & Clinical Research in Malaysia

International Council of Harmonization (ICH): GCP Compared to Malaysian Guideline for GCP

Break

Ethical Issues in Clinical Trial

Clinical Trial Protocol

Investigator’s Responsibility

GCP 4th Edition Book: Navigation Guide

Informed Consent Process

Adjourn

Welcoming

Role of Study Coordinator (SC)

Sponsor’s Responsibility

Safety Monitoring and Reporting

Quizzes / Group Exercises

Investigator Brochure (IB) & Essential Documents

Audit Inspection

Examination Briefing & Adjourn

Registration & Breakfast

Regulatory Aspects of Clinical Trials in Malaysia

Good Clinical Practice (GCP) Inspection

Self-Preparation for Examination

GCP Certification Examination

About Organizer

Newcastle University
Medicine Malaysia
(NUMed)

With its distinct heritage that dates back to 1834, Newcastle University in the UK has gained a strong reputation for innovation and excellence, with its medical and biomedical sciences programme in particular, being highly regarded the world over.

The opening of its international campus, Newcastle University Medicine Malaysia (NUMed), in Johor, Malaysia, in 2009 has made quality UK education more accessible to Malaysians as well as those around the region.

Bringing the best of Newcastle University to Malaysian shores, NUMed offers a Foundation in Biological and Biomedical Sciences programme alongside its acclaimed undergraduate degrees in medicine and biomedical sciences. All programmes offered at NUMed are identical to those offered at Newcastle University, UK, and lead to the award of the same qualifications, but at significantly reduced costs.

Newcastle University Medicine Malaysia

Contact Us Now !

Feel to reach out using the below details.

Get In Touch

Get In Touch

+607 555 3800
[email protected]

Address

Address

1, Jalan Sarjana 1,
Kota Ilmu, Educity@Iskandar,
79200 Iskandar Puteri, Johor

Event Date

Event Date

18th & 19th June 2025
Virtual • Zoom


20th June 2025
In person • NUMed Malaysia

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Registration

Exam Only

*By registering for this workshop, you consent to the collection and use of your personal data solely for the purpose of connecting you with the GCP workshop-related information. Your data will be handled in accordance with PDPA regulations.

Registration

Full Course + Exam (For NUMed Staff Only)

*By registering for this workshop, you consent to the collection and use of your personal data solely for the purpose of connecting you with the GCP workshop-related information. Your data will be handled in accordance with PDPA regulations.

Registration

Full Course + Exam (For MOH Staff Only)

*By registering for this workshop, you consent to the collection and use of your personal data solely for the purpose of connecting you with the GCP workshop-related information. Your data will be handled in accordance with PDPA regulations.

Registration

Full Course + Exam (For non MOH Staff)

*By registering for this workshop, you consent to the collection and use of your personal data solely for the purpose of connecting you with the GCP workshop-related information. Your data will be handled in accordance with PDPA regulations.

Registration (Full Course + Exam) >>

*By registering for this workshop, you consent to the collection and use of your personal data solely for the purpose of connecting you with the GCP workshop-related information. Your data will be handled in accordance with PDPA regulations.

Registration (For NUMed Staff Only) >>

*By registering for this workshop, you consent to the collection and use of your personal data solely for the purpose of connecting you with the GCP workshop-related information. Your data will be handled in accordance with PDPA regulations.

Registration (Exam Only) >>

*By registering for this workshop, you consent to the collection and use of your personal data solely for the purpose of connecting you with the GCP workshop-related information. Your data will be handled in accordance with PDPA regulations.