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Quest 3+ System, Registration of Pharmaceutical Products and Cosmetic Notification & Medicines Advertisement Workshop
Date : 5 - 6 November 2024
Venue : Dorsett Hotel, Putrajaya
Fees : RM 1,000 per person
(MNPS Members and those who register before 1st October will get 5% discount)
Registration Deadline : 18 October 2024
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 :
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Quest 3+ System
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Generic Drug and Health Supplement Registration
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Traditional Medicine with Therapeutic Guidelines
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Cosmetic Notification
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Good Laboratory Practice (GLP)
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Regulatory Perspective for Clinical Trial
Who should attend
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Regulatory Affairs Executive
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Product Development Executive
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Academician
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Cosmetic Business Operator
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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: Bangi Resort Hotel
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 |