Institut Biologi Sistem

 Institute of Systems Biology

Workshop Outline

Introduction :

This workshop aims to enhance participants' understanding of Good Laboratory Practices (GLP) and the registration procedures for generic drugs, traditional medicines, health supplements, and cosmetic products. Featuring expert speakers from the National Pharmaceutical Regulatory Agency (NPRA), 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

  • Generic Drug and Health Supplement Registration

  • Traditional Medicine with Therapeutic Guidelines

  • Cosmetic Notification

  • Good Laboratory Practice (GLP)

  • 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
Assoc. Prof. Dr. Mazlina Mohd Said

Universiti Kebangsaan Malaysia

Keynote 2
Prof. Dr. Faridah Abas

Malaysian Natural Products Society

Industry Talk
Mr. Leonard Ariff Abdul Shatar

Executive Director
Duopharma Biotech Berhad

Trainers

Mrs. Nurhidayah binti Baharuddin
Senior Principal Assistant Director, NPRA
Quest 3+ System

Mrs. Zarith Nadia Mohamad Zulkifli
Principal Assistant Director, NPRA
Generic Product Registration

Mrs. Nurul Nadiah Abd Rahim
Senior Principal Assistant Director, NPRA
Cosmetic Product Notification

Mrs. Kong Su Yi
Senior Principal Assistant Director, NPRA
Traditional Medicine with Therapeutic Guidelines Registration

Mr. Loo Jun Min
Principal Asistant Director, NPRA
Health Supplement Product Registration

Mrs. Tay Chai Ling
Chief Assistant Director, MOH
Medicines Advertisement

Dr. Siew Ee Ling
Senior Lecturer, UKM
Good Laboratory Practice (GLP) Overview & Preclinical Testing

Dr. Siti Hajar Muhd Rosli
IMR
Regulatory Perspective of Clinical Trial in Malaysia and Q&A

Programme

Venue: Dorsett Hotel, Putrajaya

5th November 2024 (Tuesday)

Time Activity Trainer
8.30 am Registration
9.00 am Opening remark
9.05 am Keynote 1: Advancing herbal medicine: enhancing product quality and safety through robust quality control practices Assoc. Prof. Dr. Mazlina Mohd Said (UKM)
10.05 am Photo session and morning break
10.30 am Session 1: Quest 3+ system NPRA rep.
11.30 am Session 2: Medicines advertisement MOH rep.
12.30 pm Lunch break
2.00 pm Session 3: Regulatory perspective of clinical trial in Malaysia IMR rep.
3.00 pm Session 4: Generic product registration NPRA rep.
4.00 pm Session 5: Good laboratory practices (GLP) overview and preclinical testing UKM rep.
5.00 pm Tea time and end of session

 

6th November 2024 (Wednesday)

Time Activity Trainer
8.30 am Registration
9.00 am Keynote 2 :NMR-based metabolomics approach for quality evaluation of medicinal plants Prof. Dr. Faridah Abas (MNPS)
10.00 am Morning break
10.30 am Session 6: Cosmetic product notification NPRA rep.
11.30 am Session 7: Sharing session with industry Mr. Leonard Ariff Abdul Shatar (Duopharma Biotech Berhad)
12.30 pm Lunch break
2.00 pm Session 8: Traditional medicine with therapeutic guidelines and registration NPRA rep.
3.00 pm Session 9: Health supplement product registration NPRA rep.
4.00 pm Closing ceremony
5.00 pm Tea time and end of session

Register now or contact us for more details