Institut Biologi Sistem

 Institute of Systems Biology

Workshop Outline

Introduction :

This workshop aims to enhance participants' understanding of preclinical efficacy studies, product classification, FDI, and the registration procedures for traditional medicines, health supplements and cosmetic products. Featuring expert speakers from NPRA, MOH & IMR, the programme equips industry professionals and academics with comprehensive knowledge and practical guidance on NPRA's registration and notification methods. Participants will gain valuable insights directly from regulatory authorities, enabling them to navigate compliance processes effectively and elevate the standards of their research and product development initiatives.

Objectives :

1. To provide exposure on products registration and notification in the NPRA.
2. To encourage the exchange of ideas among researchers and industry players in the field of product development and registration.

Content :

  • Quest 3+ System

  • Product Classification

  • Traditional Medicine with Therapeutic Guidelines

  • Cosmetic Notification

  • Preclinical & Efficacy studies

  • Regulatory Perspective for Clinical Trial

 

Who should attend

  • Regulatory Affairs Executive

  • Product Development Executive                                                    

  • Academician                                                                    

  • Cosmetic Business Operator

  • Anyone who wanted to update their knowledge on MOH legal requirements/guidelines and licensing

Meet the Speakers

Keynote 1
Prof. Dato' Dr. Ibrahim Jantan

INBIOSIS, UKM

Keynote 2
Dr. Ami Fazlin Syed Mohamed

Director of Institute for Medical Research (IMR)

Industry Talk
Madam Sabrina Haron

Regulatory Affairs Manager
Duopharma Biotech Berhad

Trainers

Encik Saiful Mujaheed bin Yusoff
Senior Principal Assistant Director UF14, NPRA
Session 1: Quest 3+ System and Q&A

Puan Lee Huey Yee
Senior Principal Assistant Director UF14, NPRA
Session 2: Product Classification and Food & Drug Interphase

Puan Tay Chai Ling
Principal Assistant Director UF12, MOH
Session 3: Medicines Advertisement

Dr. Hussin Bin Muhammad
Head of Herbal Medicine Research Centre (HMRC), Toxicology, IMR
Session 4: Preclinical Safety & Efficacy Study

Dr. Zaril Harza Zakaria
Head of Investigational Product Section (UF14), NPRA
Session 5: Regulatory Perspective of Clinical Trial in Malaysia

Cik Tan Xin Ci
Senior Principal Assistant Director UF12, NPRA
Session 6: Traditional Medicine with Therapeutic Guidelines Registration

Puan Ng Chin Teng
Senior Principal Assistant Director UF14, NPRA
Session 7: Health Supplement Product Registration

Puan Chan Yoke Jia
Senior Principal Assistant Director UF14, NPRA
Session 9: Cosmetic Product Notification & PIF

Programme

Venue: Bangi Resort Hotel

4th February 2026 (Wednesday)

Time Activity Trainer
8.30 am Registration
9.00 am Opening speech YBhg. Puan Wan Noraimi Wan Ibrahim [Director of NPRA]
9.05 am Keynote 1 Prof. Dato’. Dr. Ibrahim Jantan [UKM]
10.05 am Photo session and morning break
10.30 am Session 1: Quest 3+ System and Q&A  En. Saiful Mujaheed Yusoff [NPRA]
11.30 am Session 2: Product Classification and Food & Drug Interphase
 Puan Lee Huey Yee [NPRA]
12.30 pm Lunch break
2.00 pm Session 3: Medicines Advertisement
 Puan Tay Chai Ling [MOH]
3.00 pm Session 4: Preclinical Safety & Efficacy Study Dr. Hussin Bin Muhammad [IMR]
4.00 pm Session 5: Regulatory Perspective of Clinical Trial in Malaysia
 Dr. Zaril Harza Zakaria [NPRA]
5.00 pm Tea time and end of session

 

5th February 2026 (Thursday)

Time Activity Trainer
8.30 am Registration
9.00 am Keynote 2  YBhg. Dr. Ami Fazlin Syed Mohamed
[Director of IMR]
10.00 am Morning break
10.30 am Session 6: Traditional Medicine with Therapeutic Guidelines Registration Cik Tan Xin Ci [NPRA]
11.30 am Session 7: Health Supplement Product Registration Puan Ng Chin Teng [NPRA]
12.30 pm Lunch break
2.00 pm Session 8: Sharing session with Industry : Latest Trends and Challenges in The Regulation of Pharmaceutical Industry
 Madam Sabrina Haron,
Duopharma Biotech Berhad
3.00 pm Session 9: Cosmetic Product Notification & PIF Puan Chan Yoke Jia [NPRA]
4.00 pm Closing ceremony of Professional Certificate and Workshop YBhg. Prof. Dr. Syarul Nataqain Baharum [Director of INBIOSIS, UKM]
5.00 pm Tea time and end of session

Register now or contact us for more details